Medical Product Outsourcing

Diagnostics

Abbott's Panbio Rapid COVID-19 Antigen Test Earns CE Mark for Two New Uses

EU approves symptomatic screening and self-administered sample collection with nasal swab.

Sam Brusco, Associate Editor 01.26.21

Cardiovascular | Surgical

Abbott Wins Expanded Medicare Coverage for MitraClip

Includes patients with secondary (or functional) mitral regurgitation resulting from heart failure.

Abbott Laboratories 01.20.21

Diagnostics

Abbott to Supply Additional 30M COVID-19 Tests to U.S. Gov't

Company is in final stages of completing its self-funded capacity expansion across U.S. manufacturing sites.

PR Newswire 01.13.21

Diagnostics | Neurological

FDA OKs Abbott's First-of-Its-Kind Rapid, Handheld TBI Test

Produces a result within 15 minutes after a plasma sample is inserted.

Abbott Laboratories 01.11.21

Diagnostics

FDA Authorizes Abbott's Rapid, $25 COVID-19 Test for At-Home Use

Telehealth service will take users step-by-step through the sample collection process.

U.S. Food and Drug Administration 12.17.20

Diagnostics

Abbott's COVID-19 IgG Quantitative Antibody Test Wins EU Approval

Identifies levels of IgG antibodies that attach to the virus' spike protein.

Abbott Laboratories 12.16.20

Cardiovascular

Abbott Launches OCT Virtual Reality Training for Cardiologists

VR training improved cath lab staff learning engagement by 45 percent, knowledge retention by 72 percent.

Abbott Laboratories 12.09.20

Former Abbott Executive Appointed President of PQ Bypass

New leader has nearly 30 years of healthcare experience.

Business Wire 11.13.20

Former Abbott Executive Joins Centricity Vision Board

New member has more than four decades of business and ophthalmology industry experience.

Business Wire 11.11.20

Diagnostics

Abbott's COVID-19 IgM Test Receives EUA

Test demonstrated 99.56 percent specificity, 95 percent sensitivity for patients tested 15 days after symptom onset.

Abbott Laboratories 10.12.20

Diagnostics

Abbott Shares ID NOW COVID-19 Interim Clinical Study Results

ID NOW performance of 95 percent sensitivity, 97.9 percent specificity within seven days of symptom onset.

Abbott Laboratories 10.07.20

J&J, Abbott Medical Executive Named Chief Commercial Officer at WaveFront Dynamics

Latest hire brings more than 20 years of medical device business experience to the position.

Business Wire 10.02.20

Chronic Disease

Abbott's FreeStyle Libre 3 Receives CE Mark

Features world's smallest, thinnest sensor with best-in-class performance at the same low cost for people with diabetes.

PR Newswire 09.28.20

Cardiovascular

Abbott’s MitraClip G4 Receives CE Mark

Offers physicians an innovative system with more options for mitral valve repair using proven clip-based technology.

Abbott 09.21.20

Patient Monitoring

Abbott Introduces World's First Glucose Biosensor Designed for Athletes

The firm is collaborating with Supersapiens in launch of the Libre Sense Glucose Sport Biosensor in Europe.

PR Newswire 09.18.20

Cardiovascular

Abbott Begins Study for New Esprit BTK Fully Resorbable Stent

Will evaluate bioresorbable device to treat blocked arteries below the knees.

PR Newswire 09.03.20

Diagnostics

Feds to Buy $760M of Abbott's $5, 15-Minute COVID-19 Test

150 million tests, which require no lab equipment, will be strategically distributed to where they’re needed most.

HHS.gov U.S. Department of Health & Human Services 08.28.20

Diagnostics

FDA Grants EUA to Abbott's $5, 15-Minute, COVID Antigen Test

Company will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October.

PR Newswire 08.27.20

Cardiovascular

Abbott Begins Study Evaluating New Device to Treat Recurrent AFib

Study will evaluate the performance of the investigational TactiFlex Ablation Catheter, Sensor Enabled.

PR Newswire 08.07.20

Abbott Vascular Executive Assumes Chief Medical Officer Role at Abiomed

Harvard-educated doctor spent nearly three decades as an interventional cardiologist.

Business Wire 08.07.20

Former Abbott Labs Exec is Named COO at Inspire Medical Systems

New hire spent a decade at Abbott Laboratories in various roles.

Globe Newswire 08.05.20

Digital Health

FDA OKs Abbott’s iOS-Compatible Therapy Management App

App allows people living with chronic pain and movement disorders to personalize therapy via their mobile device.

PR Newswire 07.23.20

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07.21.20

Abbott Agrees to Settlement with Edwards Lifesciences

All disputes related to transcatheter mitral and tricuspid repair products have been resolved.

PRNewswire 07.14.20

Cardiovascular

FDA Approves Abbott's Next-Gen Gallant ICDs, CRT-Ds

The devices feature Bluetooth connectivity and continuous remote monitoring.

PR Newswire 07.06.20

Chronic Disease

Abbott's Freestyle Libre 2 iCGM Cleared in U.S. For Adults and Children with Diabetes

Automatically alerts users when their glucose is high or low without needing to scan the sensor.

PRNewswire 06.15.20

Former Abbott Executive Recruited as Chief Commercial Officer at Endologix

New hire has more than a decade of experience in the medical device industry.

Business Wire 06.11.20

How Are MPO’s Top 30 Addressing COVID-19?

J&J's Janssen moves the start of its Phase 1/2a vaccine clinical trial from September to the first half of July.

Online Exclusives Sam Brusco, Associate Editor 06.09.20

Diagnostics

Abbott Buries N.Y. Study with Positive ID NOW COVID-19 Test Results

Urgent care clinic study shows performance of ≥94.7 percent positive agreement compared to PCR test.

Abbott Laboratories 05.22.20

Diagnostics

FDA Warns About Possible Accuracy Concerns With Abbott Coronavirus Test

Agency claims ID NOW may return false negative results; Abbott says some studies are investigating the test's role in ways it was not meant to be used.

PR Newswire 05.15.20

Diagnostics

Abbott Earns EUA for COVID-19 Molecular Test on Alinity m System

Ths system runs up to 1,080 tests in 24 hours.

PR Newswire 05.13.20

Diagnostics

Abbott’s COVID-19 Antibody Blood Test Gains EUA for Use on Alinity i System

Plans to ship nearly 30 million antibody tests globally in May across its Architect and Alinity i platforms.

PR Newswire 05.11.20

Cardiovascular

BIOTRONIK's Ultrathin Strut Drug-Eluting Stent Outperforms Abbott's Xience

Company's stent has been used to treat more than 2 million patients worldwide to date.

PR Newswire 05.01.20

Medtech Execs Named to White House Economic Task Force

Will provide recommendations on how best to safely reopen U.S. economy in the wake of the COVID-19 pandemic.

AdvaMed 04.15.20

Diagnostics

Abbott Launches COVID-19 Antibody Blood Test

Abbott begins shipping April 16 and intends to distribute 4 million tests in April.

PR Newswire 04.15.20

Cardiovascular

Abbott's TriClip Transcatheter Tricuspid Valve Repair Gains CE Mark

The device is delivered to the "forgotten heart valve" through the femoral vein in the leg.

Abbott 04.09.20

Chronic Disease | Patient Monitoring

FDA OKs Abbott's FreeStyle Libre CGM Use in Hospitals

Remotely monitors patients with diabetes to minimize exposure to COVID-19.

PR Newswire 04.08.20

Mike on Medtech: COVID-19, Part 1

Mike Drues and Sean Fenske discuss Emergency Use Authorization and the potential problems with non-medical device manufacturers producing ventilators.

Sean Fenske, Editor-in-Chief 04.01.20

Diagnostics

COVID-19 Test Availability Rapidly Scales Up

The industry rallies to boost production.

AdvaMed 04.01.20

Diagnostics

New Test Can Diagnose COVID-19 in as Little as Five Minutes

Abbott Laboratories will be making ID NOW COVID-19 tests available next week and expects to ramp up manufacturing to deliver 50,000 tests per day.

Abbott Laboratories 03.28.20

Diagnostics

UC San Diego Partners with 5 Dx Manufacturers to Boost COVID-19 Testing

The University is working with Thermo Fisher, Roche, GenMark, Luminex, and Abbott.

University of California - San Diego 03.23.20

Diagnostics

Diagnostics Manufacturers Ramp Up COVID-19 Tests

By April, production will more than double.

AdvaMed 03.20.20

Former Visiogen Chief Executive Tapped to Lead PROCEPT BioRobotics

New CEO also held the top position at Avedro, which was acquired by Glaukos in November 2019.

Business Wire 03.19.20

Diagnostics

FDA OKs Abbott's COVID-19 Molecular Test

Abbott is shipping 150,000 laboratory tests immediately.

PR Newswire 03.19.20

Surmodics Names New Vice President of Clinical Affairs

Former Edwards Lifesciences executive has more than 20 years of medical affairs, medtech, and healthcare experience.

Business Wire 03.13.20

Cardiovascular

CE Mark for Abbott’s FlexNav Delivery System for TAVI Valve

The system improves control and delivery of the Portico TAVI valve even in complex clinical cases.

PR Newswire 03.05.20

Cardiovascular

Getting to the Heart of the Matter: An Examination of Transcatheter Heart Technologies

Transcatheter structural heart therapies stand to replace their open-heart counterparts thanks to technological innovations and expanded patient access.

Sam Brusco, Associate Editor 03.04.20

Dawn of a New Decade: Looking Ahead to Medtech’s Future

The start of the '20s offers the industry an opportunity to build value through new tech., collaborations, clinical validations, and value-based outcomes.

Mark Bonifacio, President, BCS LLC 03.04.20

Diagnostics