Purchases Axsun Technologies Inc. for $21.5 million in cash
The company was sued over a heart valve component agreement.
The company is awaiting approval from shareholders, Bermuda court
The products use two methods to treat the condition
The alert follows a warning letter, which was issued in March
The St. Paul-MN company is acquiring Radi Medical AB and MediGuide Inc.
The program, which begins April 1, mandates a boost in user fees
The heart valve maker is taking this action after legislation has been introduced by an Iowa senator.
The Bermuda-based healthcare product company's next step is to train healthcare providers.
The review is continuing after Michael Gluk has left the Austin, TX-based company.
The acquisition of the Uppsala, Sweden-based company gives St. Jude the opportunity to develop a global vascular closure device market.
The FDA says the Somerville,NJ-based company did not document potential sealing problems with the Strattice device.
But a study finds that the mortality death increases slightly after three years.
Claims Engenex negative pressure wound therapy is too closely based on KCI’s proprietary Vacuum Assisted Closure, or V.A.C., Therapy System.
The company will fire 71 employees, a Web site says.
Research finds physicians go with medical devices they're familiar with.
The Advanced Medical Technology Association is supporting Japan on its updated medical device review process.
Abbott Labs bought the remaining stake in Ibis for $175 million
The FDA is saying two unapproved medical devices could cause injury or death.
Move is designed to boost the company's surgical care business
Import alert affects heating pads produced by Teamedics Manufacturing
Company failed to notify FDA when device broke
In Singapore, ads cannot use testimonials from health professionals
Fuji System accused of failing to validate its processes for silicone tubing extrusion
Patients who have had previous pocket procedures are most at risk
Kinetic Concepts is filing more claims against Smith & Nephew in an ongoing patent infringement lawsuit.
A Minnesota state senator wants medical device makers to to publicly report gifts to doctors.
A just ruled that Medtronic was in the wrong for infringing on a patent for artificial discs.
The FDA has decided a handgun meant for the elderly is not a "medical device."
GE Electronic imaging is planning to slash costs and jobs, but executives are staying mum on details.
The FDA has issued a warning letter to Innovative Neutronics after the medical device maker failed to act on agency mandates.
The FDA is closely watching medical devices containing BPA.
Medtronic is denying responsibility for the death of a California woman.
Three companies are investing $11 million in Endoscopic Technologies.
A senator from Ohio wants more information on imported dental implants.
A disclosure report reveals that Covidien spent $450,000 on lobbying in the third quarter.
Move expected to save the company $2 million
Company focused on health care legislation
Deal worth $1.1 billion
CEO says company will cooperate with investigation
Study finds devices being used too often in the wrong patients
Sales rep admits misbranding medical devices
Facility will manufacture surgical instruments
Two subsidiaries held liable for woman's death
Company also is moving out of a leased facility in Minnesota
Company trims staff by 5%
Additional staff, new application procedures attributed to accelerated approval time
PRIDE Industries starts medical device manufacturing effort
MDRs were not submitted to FDA
New design gives clinicians more control
New fee takes effect April 1
Slowdown is starting to affect the medical device industry
FDA finds fault with devices manufactured at Puerto Rican facility
Update designed to better meet devicemakers' needs
New office has eight American employees
Scientists claim top managers interfered with reviews of medical devices
Age and gender are important to the success of hip resurfacing, research shows
First phase of revisions to take effect Dec. 8
Pair to develop device that can detect carbon monoxide poisoning
Seeks permanent injunction against company
Service lowers outlook for the sector
FDA warning is the company's third in just over a year
Medtronic gains 96.3% of CryoCath's issued and outstanding shares
New firm will focus on acquiring medical device companies and products
Theft of intellectual property presents challenge, expert claims
New study finds that nanoporous ceramic membranes could reduce chances of rejection
Deal would give Endocare shareholders 52% stake in the combined company
Study suggests MP3 players be 1.2 inches from implanted devices
Company's daily wear lenses are now considered 'adulterated'
Study reveals benefit of using drug-eluting stents on diabetic patients
Directive would cover wide range of activities
Recall prompted by possible mislabeling
CEO claims company has addressed issues
Colorado judge ruled in favor of preemption
Merger to create new company
Company to eliminate 300 jobs worldwide
Sour economy forcing people to delay medical treatment
All-stock deal worth $40 million
Letter classifies OvaSure as a medical device
Growing number of medical schools restricting industry gifts and compensation
Deal with Replidyne will create NASDAQ-listed medical device company
Position contradicted views of FDA senior career staff
Face increasing pressure from federal government
Move will help company 'optimize its operating footprint'
Company’s surgical ablation devices at center of investigation
Startup ran out of money
Abbott files lawsuit against Medtronic over Rapid Exchange system
Company does not expect to regain the customers it has lost
Violations uncovered during summer inspection
Minimally invasive surgical techniques are gaining momentum
Medical device was the subject of $14.7 million patent-infringement verdict
Move expands GE's monitoring, anesthesia and respiratory care offerings
Gore's Helex Septal Occluder Devices in question
Johnson & Johnson files new lawsuit over old patent
More than 60 regulators to be stationed overseas
Tiny pieces of wire left near hearts of patients
Policy goes beyond guidelines of American Medical Society and most state medical societies
FDA lets thousands of devices onto the market each year after only cursory review and no clear evidence they help patients
Five people have died using the device
Figure represents best quarterly performance in eight years
Company leasing 22,422 feet of space in Discovery Park
Firm developing device to determine whether osteoarthritis patients would benefit from cartilage repair or joint replacement
Nine manufacturers report erosion of device in patients
iPro 8000 MP SLA precision center is ideal for mass customization of orthodontics, implant drill guides
Violations uncovered during inspection of plant
Suit comes on heels of FDA investigation
Two Senate committees investigating ties between Columbia University, Cardiovascular Research Foundation
Company leased space in Research Triangle Park
Company given one-year extension on patent
Official claims FDA must shift its approach on imports
Company filled orders without testing some devices before shipping them
N.Y. hedge fund also eyeing business software firm
Setback could delay launch in the U.S.
Ruling allows company to continue expanded evaluation
Woman claims surgeon used the device without her consent
Company holds slightly less than half the US market for drug-coated stents
Manufacturing problems uncovered during inspection
Both brands fared well at restoring blood flow to the heart
Lawmaker suggests equal regulatory oversight be applied to medical device DTC advertising as to pharmaceuticals
Company did not establish certain manufacturing control procedures for generator kit
Company made significant changes to device without submitting premarket notification
Devicemakers that submit ISO reports could avoid agency inspection
Decision leaves $703 million award against company intact
Expert predicts chemical will be a concern for industry
FDA claims unapproved device lacks safety and effectiveness data
Favorable patent dispute ruling could give heart stent $114 million sales boost
Program designed to cut costs
FDA updates guidance for makers of ultrasound equipment and intravascular administration sets and accessories
Congress agrees to extra money
Credibility of the industry is at stake
FDA cracking down on conducting device clinical trials
Purchase price was $78.4 million in cash
Report will likely re-categorize Class II devices
Notification relates to the improper connection of its sutureless connector intrathecal catheters
Despite multiple lawsuits involving recalled device, company insists it acted responsibly
Medical device manufacturers are hesitant to participate
Hiring in the medical device field has evolved into a recruiter's market
Suit claims alleged kickbacks were
Agency clarifies December 2007 health notification on use of RF ablation devices
Death rates lower for patients receiving drug-coated stents, study finds
Company to cooperate with inquiry
Private investment in sector remains strong
Medical device companies push to ensure technology is not targeted by federal cost-cutting efforts
Actions follow cost-cutting plan announced in April
Facility to become operational in 2011
Company hopes to resolve issues with regulators so it can launch its next-generation device
New warehouse and distribution facility underway
FDA, University of Pennsylvania sign memorandum of understanding
Deal worth $865 million
Invitrogen still hopeful $6.7 billion acquisition will occur
Judgement caps 11-year patent battle with Medtronic and Boston Scientific
Clinical and medical products businesses become a separate public company
Study conducted by the Cleveland Clinic
Device firms step up efforts to reveal relationships with doctors
Lawmakers, medical groups want restrictions on advertising
Financial details not disclosed
Deal worth $380 million
Active Implants pairs with InMotion to test new medical device
Federal judge grants motion for final judgement against Boston Scientific
Company failed to get marketing clearance for sterilization wraps
Minimally invasive medical products are steadily gaining ground
Financial details of supply agreement not disclosed
Sector attractive to investors seeking safety amid global economic slowdown
Lack of dialogue prompts pullout
Technology, market shifts challenge regulators
Inspections do not occur as frequently as law requires
Patients with allergies to metal are at risk for recations to implanted devices
Company jointly served by the FDA and US Immigration and Customs Enforcement
Firm has hired Eisner Safety Consultants to gain FDA compliance
Company investing nearly $71 million in Galway plant
Move intended to help Tronics develop more specialized medical devices
New report stresses safety, efficacy of FDA's medical device approval process
The enterprise value of the US firm is $10 million
Deal worth $360 million in cash
Private equity firm leads buyout of Indiana device maker
FDA claims Volk Optical overlooked numerous complaints involving the possible malfunction of diagnostic contact lenses
FDA cites X Spine Systems for failure to correct quality problems
Deal worth $18 million
'Infuse Bone Graft' linked to life-threatening complications
New FDA rule to take effect Sept. 22
Complaint alleged against company that filed two patent complaints against Terumo
Abbott seeking patent extension through 2011
MedSystems is renamed Corpak MedSystems
Stent made with biodegradeable drug coating
Company receives $167 million reduction in patent verdict
All claims between the companies have been dismissed
Patent set to expire on Oct. 29
Probe threatens to upend $1.8 billion market
Adverse incidents occurred after Encore Medical identified problem with muscle stimulators
Family’s claims are based on violations of federal law
Court decision a victory for small orthopedic device manufacturer
Thoracic aortic aneurysm stent grafts will now be tracked
Company sparring with government over 'oppressive' subpeona
New group focused on investing in companies developing new medical devices, diagnostics and pharmaceuticals
Move is part of a multiyear effort to lower spending on its medical testing business
Rule limits changes companies can make to product warnings
HDE approval is based on safety and probable benefit
Manufacturing plant will produce pacemakers and cardiac leads
New standards are meant to test and verify medical devices
Lawsuit filed against NuVasive
Relocating R&D and manufacturing from California to Michigan
Company preparing for clinical trials
Company is doubling in size
Representatives of the pharmaceutical and biotech industries opposed the legislation
Company allegedly failed to establish written procedures for numerous good manufacturing practice requirements
X Spine must address 12 alleged failures
Layoff notices issued to 350 as part of the 16,750 job cuts announced in July
Accuses two companies of infringing a patent for a stent used in the treatment of blood vessels
FDA cites company for failing to have hand-washing sink outside sterile gowning room
Company cites issues with stent delivery system
Calls $26.9 million offer 'inadequate'
Six joint implant manufacturers accused of selling inferior and more costly products
Wall Street Journal claims company used faulty data in study of drug-coated stent
An effective audit program must streamline auditing and assessment processes
Senate version co-sponsored by Democratic Sens. Edward Kennedy and Patrick Leahy
Deal worth $24 million
SurgRx’s EnSeal line will provide a new platform for Ethicon’s ultrasound devices
Warning is related to the company's hot and cold compresses
Fewer than half of eligible patients were implanted with medical devices for their heart
Deal worth $26.9 million
Technology for patient monitoring will complement an existing Covidien product
Company's profit tumbles 64%
S&N finds
Company focusing on raising funding
New line of stents entering the American and European markets this year
Subpoena part of broader probe affecting Abbott Laboratories and Boston Scientific
Program would search public and private databases
Defective device was distributed worldwide
Immunicon filed for bankruptcy to facilitate transaction
Survey included responses from 221 employees in the medical device industry
Company resolves lawsuit with General Electric
ArthroCare to reissue its financial statements from 2006 through 2008
Abiomed has already added positions at its Massachusetts headquarters to handle new work
Remediation efforts result in more efficient manufacturing
Specialty Needle Manufacturer Continues to Diversify Theragenics Business
Company allegedly did not evaluate or investigate four complaints about needle sticks
Move will expand GE's $17 billion health care operation into the single-use products market
Doctors complained device was failing at a high rate
Problems uncovered during March inspection
Move is part of FDA effort to improve monitoring of imported products
“Closed-loop system” could reduce a manufacturer’s exposure
Deal worth $47.8 million
Ability to better identify problems requires substantial resources
Recall follows reports that equipment broke during surgery
Guidance will explain how FDA will interpret International Organization for Standardization audit reports
Company discovers catheter was inadequately attached in several cases
Bill removes barriers to plaintiffs initiating private lawsuits against manufacturers
Johnson & Johnson, Boston Scientific appear to be most vulnerable to the increased scrutiny
Company plans to appeal ruling
Novartis completes first stage in takeover of eye-care company
Company also consolidating its business into two primary segments.
Companies collaborate to develop miniature wireless sensing solutions for implantable medical markets
Deal augments St. Jude programs to treat atrial fibrillation
Lawsuit claims surgical instruments were sterilized in hydraulic waste fluid from elevators
VNUS seeking monetary damages and wants companies to stop selling products
Wound care business generated $270 million in sales last year
Move expected to save company more than $1 million
The agency took an average 335 days in 2006 to approve devices
Companion legislation expected to be introduced in Senate
Company should have submitted new application for manufacturing modifications to its System 1 Processor
Center facilitates production of device prototypes
Deal worth $77.7 million
System designed to provide surgeon flexibility
Deal expected to cut costs, improve quality, and speed time to market
Swedish firm develops technology for faster diagnostic tests of patient blood samples.
Sales raise $140 million for acquisition costs
Move to Wayne, N.J. expected to be completed by 2009
Cardo Medical will become a wholly owned subsidiary of clickNsettle.
Move is expected to raise more than $100 million in pre-tax proceeds
Deal is worth $11 million
U.S. medical device companies fear boost in state lawsuits.
Executive wants to pursue 'outside opportunities' and spend more time with family.
The $1.5 billion deal marks Ares' first acquisition since it was established by Ernesto Bertarelli, a Swiss-Italian biotech billionaire.
Deal valued at $6.7 billion
Smith & Nephew awarded $14.7 million for infringement
Company says stent market will never regain its total worth before safety issues drove down sales
Company to supply Toshiba with medical imaging subcomponents.
Purchase occurs one week after company considered selling itself
Offer would create the biggest "stand-alone" molecular diagnostics company
Deal worth $580 million
Most cases involved heparin used to clean intravenous lines
Deal worth $68 million
Violations include the use of unapproved and obsolete documents.
Company claims 'third parties' considering making bid
VNUS to grant AngioDynamics and Vascular Solutions a patent license
Deal valued at up to $24 million
Company plans to reinvest the money into product development
SonoSite Inc. calls suit "baseless and without merit."
Boston Scientific Corp. must pay $250 million for infringing patents on catheters
Company accused of using phony consulting agreements with orthopedic surgeons
Some say resignation advances Hologic's integration with Cytyc Corp.
Terms of the sale include $982,000 in cash to Cyberkinetics by July 1
Deal clears way for LifeCell to become a wholly owned subsidiary of KCI
Complaint requests court order blocking merger agreement
Device manufacturers given ways to prove their product conforms to safety principles
Transaction Worth $240 Million
The acquisition includes over 15 issued patents
Deal expected to close by second half of the year
ConvaTec business unit sold to Nordic Capital Fund
Deal gives NuVasive developing stem cell technology
Canadian court dismisses patent infringement suit
Agency reviewing procedures for the appeal and dispute process
Affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries
Acquisition is expected to help ArthroCare boost long term revenue growth potential
Move is designed to consolidate part of company's operations
Cuts are part of company's global restructuring
Trial ordered in patent infringement suit
FDA approval of device could lead to higher profits
Company discovers Plus Orthopedics giving kickbacks to purchasers
Hip implant franchise took a $15 million to $20 million hit last quarter
Violations are related to company's computed tomography and nuclear imaging systems
Acquisition is expected to close in the second quarter
Advisers will ask the FDA to boost oversight of laser eye surgery
One dozen production problems found at Ohio manufacturing plant
Closing comes eight months after Boston Scientific acquired the medical device start-up.
The firms will cross license future capsule endoscopy products.
Deal is expected to close within 90 days.
News » 2008
