Veryan Medical presented data in Europe.
The company can accommodate small-volume orders as well.
Company may open a product development center where the Mass. plant used to be.
New hires are part of an expansion of services on the continent.
The system treats deep vein thrombosis and pulmonary embolisms.
The image clarification technology allows more implant patients to use MRI effectively.
Patients with dual-chamber ICD experienced less inappropriate shocks.
The system is not approved for sale in the United States.
Department put out a bulletin detailing concerns and possible solutions.
Trial studied ventricular pacing in patients.
Products are designed for wound care and prosthetics applications.
New exec will continue to head a company division until replacement is found.
FDA activity is on the rise across the board.
Suit alleges false marketing of its Da Vinci surgical system.
The company is pursuing FDA approval for the treatment of heart vessel blockage.
In wake of Riata lead controversy, the company is focusing heavily on reduced risk for abrasion.
The device monitors respiration rate acoustically.
Company says the single-lead system poses less risk than multi-lead devices.
Hill-Rom's updated system uses airway oscillation and pressure to deliver therapy.
The clamp was developed in collaboration with U.S. military
Key features are longer battery life and improved response rate.
High-risk devices do not have sufficient oversight, proposal suggests.
Factory is company's second ultrasound manufacturing facility.
Ironically, the reform bill comes from one of the device tax's authors.
Agency considers stricter review and approval pathways.
The products come in various sizes and include patented design features.
New executive will oversee device clinical trial.
The company is seeking additional patents in Europe, the United States and Japan.
The system is already CE marked.
The new facility was purchased from Sanmina SCI.
Device tracks ideal location for catheter insertion.
Trial expected to take place at up to 25 U.S. centers.
The company adds two new divisions.
Reports have been received of system tip separation.
A new study suggests robotics may not offer any real advantage over traditional surgery.
Impetus was the complexity of distribution licensing laws nationwide.
The new center will provide several medical device manufacturing services.
The deal is valued at $3 million.
Device is hoped to replace space-hogging equipment in surgical environments.
The Secretary testified before the Senate budget committee.
The new device comes with multiple kit and sizing options.
A dedicated officer is almost a requirement to navigate current compliance law.
Better talent, more staff and new guidances in the pipeline.
OEM demand for near-shoring is on the rise.
Smiths will integrate its infusion systems with the medical records software.
Now devices can be used percutaneously.
John Gordon Harold, M.D., began practicing cardiology in 1985.
Industry group hires pair to recruit new members, integrate existing ones.
Intellectual property laws are too restrictive, he said.
Company claims system reduces surgical errors.
FDA advisory panel recommended approval for the device by an overwhelming majority vote.
The medical device company is not a defendant.
The device has wireless capabilities.
CEO leaves with a good record.
The new device adds an ePTFE graft to the older version.
The sheath is for endovascular repair devices.
In comments to the IRS, AdvaMed demands clarification of tax rules.
Company shuffles executives after eight years of growth.
Acquisition expands Mar Cor's product line offering.
G-Med North America performed the audit.
Appointee is a physician with a wealth of executive experience
Deal will be funded by share sales and cash reserves.
Announcement follows appointment of new COO.
A new report claims better interoperability could save $36 billion.
The technology was developed by Soma Access Systems.
FDA to release device tax guidance for mobile apps by year's end.
Company promotes 12-year employee to the position.
Low radiation exposure an attractive feature to Japanese patients.
The new location is doubles the size of the old facility.
A non-binding amendment, the vote merely demonstrates the will to push repeal through if possible.
The portfolio is the first offering from Cook's new clinical division.
Senators hopeful that the president would change his stance on tax repeal.
Though a split decision, the device will now be up for approval.
The company provides flow control solutions.
The stencils will support the university's stem cell research efforts
FDA has classified the recall Class I.
Change will expand the treatable patient base.
Two New York hospitals have installed the company's colonoscopy systems.
Cordis intends to levy FSS' stent technology to address unmet needs in peripheral artery disease.
Device is an upgraded version of the original Ilumien system.
New hire leaves her post at GlaxoSmithKline to manage BD's medical and R&D operations.
The next step is for the FDA to approve a Humanitarian Device Exemption.
The letter comes after an inspection of the company's Instruments division.
The company invested in Core Manufacturing, formerly controlled by the Alfred Mann Foundation.
Plans for the app include the capability to capture patient vital sign data through a series of portable wireless sensors.
The company will be folded into Saint-Gobain's Fluid Systems division.
App is the third to earn European approval as a medical device.
The catheters are designed to assist with guide wire placement.
The metal component company celebrates 65 years of business this year.
The quadripolar leads are not yet approved for sale in the United States.
Medical device companies are shifting their tax burden to hospitals, which already have a tax burden of their own under ACA.
Ethicon subsidiary maintains device failure was within standard risk of complications.
Move follows company's split into two different firms.
The agency will be accepting input until May 10.
New member is chairman and CEO of Conceptus.
The extended lengths will benefit heart patients with diabetes.
Allergan will be required to perform long-term post-op studies to ensure safety.
Facility expansion caps 8,500 square feet.
Money will fund U.S. trial for renal device.
Executive brings three decades of medical device experience.
A declining trend was reversed in 2011, and with MDUFA only promises to get better.
Second Sight Medical Products provides hope for those with retinitis pigmentosa.
Latest expansion is part of a global growth strategy.
COO will retain his previous responsibilities of senior VP and CFO.
Xagenic will receive approximately $1 million in this round of financing.
New appointee brings academic and industry experience to the table.
Deal gives Cardinal access to home healthcare market.
Company reports positive results from two-year study.
Platform combines TissueGen's knowledge in drug delivery with BMS' textiles experience.
Facility enhances firm's biomaterials R&D offerings.
Concerns over fracture of wire prompts latest high-risk recall effort.
U.S. Supreme Court refuses to hear Gore appeal.
Firm allegedly imported unlicensed products into country.
Executive has extensive financial background.
BMS CEO remains, MPC CEO to become chief tech officer.
AdvaMed cries foul.
Supporters try to build more momentum within a new session of Congress.
The unit opens door to neurodiagnostic research market for Natus.
Acquisition comes shortly after executive shuffle.
Company appoints cardiac CEO as replacement for outgoing member.
New line offers longer battery life of up to a decade.
Director has extensive Indiana state legislative experience.
Acquisition part of company strategy to grow healthcare business.
The endoscopy company expects target market segment to continue growing at rapid rate.
The software is targeted specifically at prostate cancer.
Company gets the new year rolling with trial to treat uncontrolled hypertension.
Reports are trickling out of unexpected effects of excise tax.
Appointee also will serve on the board.
The implants are intended to treat chronic back and leg pain.
After an unsatisfactory close to 2012, company trims the fat.
The device has been updated to fix minor issues.
Several balloons in this series have been approved for sale outside the U.S.
The new VP comes with experience in diabetes devices.
Prefilled syringes are hoped to replace older glass ampules.
Deal adds microwave ablation technology to company portfolio.
Agency releases communication on implants' effect on soft tissue.
FDA-cleared assay tests for common gastroenteritis-causing pathogens.
New recruit is a 25-year medical device veteran.
This year, the name of the game is wireless monitoring.
The trials evaluate pacemakers and cardiac monitors in specific patient populations.
The pledges will make patient data collected and displayed on their devices accessible for patients and clinicians.
Company seeks a more strategic location following approval of its flagship device.
The two companies already share several OEM clients.
Assay is designed to identify commonly transmitted but curable STD.
Public and stakeholder comments are encouraged.
Brainsway product targets patients unresponsive to therapy.
Industry veteran brings engineering, marketing experience to the company.
Team is selling new uterine fibroid treatment device.
VP of national accounts has two decades of manufacturing experience.
Acquisition adds new neurodiagnostic and monitoring products to company's offering.
California firm sets its sights on Europe.
Overseas office will focus on R&D.
The new system comes in wide array of sizes.
The expansion will support the company's engineering center.
Lifecodes offers transplantation diagnostics devices.
Departing director to be replaced by former Synovis executive.
FDA decree prompts reduced production and layoffs at company headquarters.
Purchase of CV Ingenuity adds significantly to R&D spend.
Though a fiscal cliff deal was reached, cuts to Medicare provider compensation prevailed while the device tax came into effect on Jan. 1.
Money intended to secure future of state medtech jobs.
Dynaroll is the company's fifth acquisition in its two-year history.
AFC manufactures containers for use in cancer therapy.
Device makers have additional month to renew registrations with agency.
AdvaMed, UL EduNeering create regulatory and compliance certificate.
New name better reflects business model.