Edwards gets FDA approval for Sapien 3 in new patient population

The PMA expands the transcatheter valve for use in congenital heart defect patients who suffer problems following surgical repair, positioning the device to compete against a range of treatment options.

By Nick Paul Taylor • Sept. 8, 2020

Roche COVID-19, flu combo test gets FDA emergency authorization

It is the fourth EUA for a diagnostic that detects and differentiates the viruses. However, the company claims to be the first commercial test that runs on fully automated high-throughput systems using a single sample.

By Greg Slabodkin • Sept. 4, 2020

Explore the Trendline➔

Top 5 stories from MedTech Dive

From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

FDA flags 428 spinal cord stimulator patient deaths, urges more tests before implant

The agency revealed the figures in a letter to healthcare providers urging simulations prior to permanently implanting the devices, sold by companies such as Abbott, Boston Scientific, Medtronic and Nevro.

By Nick Paul Taylor • Sept. 4, 2020

Watchdog gives high marks to CMS competitive bidding program

The Office of Inspector General probe found the agency followed procedures 97% of the time when awarding contracts for durable medical equipment, prosthetics, orthotics and supplies.

By Nick Paul Taylor • Sept. 3, 2020

Final inpatient payment rule confirms price transparency push

The American Hospital Association quickly criticized the CMS decision to move forward with collecting data on hospital median payer-specific negotiated charges to guide relative Medicare payment rates.

By Hailey Mensik • Updated Sept. 3, 2020

Boston Scientific, Stryker win CMS new tech add-on pay, BD left out

When combining eligible devices with other recipients, including drug therapies, the agency estimates spending on the payments will total roughly $874 million, a 120% year-over-year increase. 

By Maria Rachal • Sept. 2, 2020

Florida cuts ties with Quest after delayed reporting of 75K COVID-19 test results

Gov. Ron DeSantis ordered all Florida agencies to sever testing relationships with the lab giant, which apologized for the delay in getting data to state health authorities in the timely manner required by law.

By Susan Kelly • Sept. 2, 2020

Stryker reaches agreement with Colfax for Wright Medical deal divestitures

The medtech disclosed Thursday the orthopaedics competitor's DJO Global subsidiary agreed to acquire its ankle and finger joint replacement businesses to shore up U.S. and U.K. antitrust concerns.

By Maria Rachal • Updated Oct. 16, 2020

HHS terminates Hamilton, Vyaire ventilator contracts

The Strategic National Stockpile now has an adequate supply of the devices, the agency said. The two companies will not deliver the additional 38,000 ventilators they'd planned by year's end.

By Greg Slabodkin • Sept. 2, 2020

UK outlines post-Brexit medical device regime starting January

Regulators unveiled a future U.K. Conformity Assessed (UKCA) mark, but will continue recognizing CE marks until mid-2023 and give companies four to 12 months to register their devices and in vitro diagnostics.

By Nick Paul Taylor • Sept. 2, 2020

HHS backs COVID-19 antigen testing for nursing homes, preempting regional restrictions

Although some state and local authorities are concerned about the accuracy of such rapid diagnostics, sold by Abbott, BD and others, the move comes amid rising calls for their use to test large numbers of people.

By Nick Paul Taylor • Sept. 1, 2020

Medtronic artificial pancreas gets FDA nod for young kids

The medtech is introducing MiniMed 770G, a Bluetooth-enabled version of the first hybrid closed looped system to get agency approval, bridging the gap to a device launching in Europe this fall but delayed in the U.S.

By Nick Paul Taylor • Sept. 1, 2020

CMS pitches coverage of breakthrough devices in tandem with FDA authorization

The proposal follows years of AdvaMed lobbying for products awarded the special FDA designation to gain Medicare reimbursement upon clearance or approval.

By Maria Rachal , Susan Kelly • Aug. 31, 2020

FDA proposes adding patient voice in device evaluation

The draft guidance comes nearly two years after an advisory committee prioritized greater inclusion of the patient perspective in device design, development and assessment. Two more public meetings are planned.

By Susan Kelly • Aug. 31, 2020

Philips lowers 2020 outlook as HHS nixes ventilator contract

The medtech received a "partial termination" notice and will not deliver 30,700 remaining ventilators to the Strategic National Stockpile, a month after a House panel called for a probe into the roughly $647 million contract.    

By Greg Slabodkin • Aug. 31, 2020

EU MDR costing smaller medtechs 5% of their annual sales: survey

Almost 70% of 101 companies surveyed by a German software provider said they spend most of their time related to the new rules deciphering what the incoming EU Medical Device Regulation means.

By Nick Paul Taylor • Aug. 31, 2020

Abbott gets $760M contract from HHS to deliver 150M antigen tests

The deal comes just one day after the company's antigen test received FDA emergency use authorization. BD, Quidel and LumiraDx previously got the agency's nod for their diagnostics.

By Greg Slabodkin • Aug. 28, 2020

Foundation Medicine wins FDA OK for pan-tumor test as liquid biopsy market heats up

The approval for the FoundationOne Liquid CDx follows the agency's nod earlier this month for Guardant Health's next-generation sequencing diagnostic.

By Greg Slabodkin • Aug. 27, 2020

Abbott gets EUA for rapid $5 COVID-19 antigen test

As the fourth company to get the FDA emergency nod, the medtech giant's scale makes it a "significant entry [that] could help democratize testing," said former agency head Scott Gottlieb.

By Nick Paul Taylor • Aug. 27, 2020

With a one-year reprieve to EU's MDR, some procrastinate, others speed ahead

Industry is taking advantage of a long-sought delay to the regulation in different ways, but COVID-19's impact on notified body capacity, pace of information from lawmakers, and company resources are some confounding variables. 

By Maria Rachal • Aug. 26, 2020

Hospitals slam 'disturbing' CMS COVID-19 data reporting requirement

The rule also implements a CARES Act requirement that all laboratories conducting COVID-19 testing report results to HHS daily, with fines for labs that don't comply.

By Shannon Muchmore • Aug. 26, 2020

Trump admin delays final rule easing anti-kickback regs until next August

Devicemakers back proposed changes to the law, passed decades ago to deter physicians from referring patients to locations that give them a financial benefit, calling them outdated and burdensome.  

By Rebecca Pifer Parduhn • Aug. 26, 2020

FDA-industry group touts real-world evidence framework to speed test development

The Medical Device Innovation Consortium, a collaboration between FDA and diagnostics makers like Abbott and Roche, offers a roadmap as COVID-19 accelerates use of newly generated data to update emergency authorizations. 

By Susan Kelly • Aug. 25, 2020

MedTech Europe beats drum for virtual audits, IVDR delay

The one-year delay to the EU Medical Device Regulation has been crucial, but there's been "radio silence" from lawmakers on calls for a similar delay to the In Vitro Diagnostic Regulation, said regulatory lead Oliver Bisazza.

By Maria Rachal • Aug. 24, 2020

Ex-Trump FDA chief rails against new HHS policy on lab developed tests

Scott Gottlieb took to Twitter on Saturday criticizing last week's decision by the administration that FDA will no longer require premarket review of LDTs. "FDA’s ability to protect public health could be challenged," he warned. 

By Greg Slabodkin • Aug. 24, 2020