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

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

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The draft guidance comes nearly two years after an advisory committee prioritized greater inclusion of the patient perspective in device design, development and assessment.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

Cold War law invoked for BD, Quidel to prioritize antigen test contracts

The Trump administration's use of the Defense Production Act comes amid rising demand for the tests that can be less accurate than traditional molecular diagnostics, but offer results within minutes.

By Nick Paul Taylor • Aug. 21, 2020

House panel demands HHS briefing on decision to nix premarket review for COVID-19 lab developed tests

On Thursday, Energy and Commerce Chairman Frank Pallone, D-N.J., insisted the department explain its "deeply concerning" decision to allow coronavirus LDTs to come to market without FDA review.

By Greg Slabodkin • Updated Aug. 21, 2020

LumiraDx lands FDA's third COVID-19 antigen test EUA, as demand for rapid diagnostics rises

William Blair analysts questioned the immediate impact from the nod to the relatively small medtech, and instead looked ahead to the next potential big player to enter the market: Abbott.

By Nick Paul Taylor • Aug. 20, 2020

Eudamed's first section to go live before year's end

The European Commission is ready to move on the initial module of the new safety and performance database, created as part of the incoming Medical Device Regulation, ahead of a March 2021 deadline.

By Nick Paul Taylor • Aug. 19, 2020

CMS urges resumption of essential procedures, organ transplants for ESRD patients

Medicare beneficiaries with end-stage renal disease have 3.5 times heightened risk of COVID-19 infection, according to an HHS analysis of early claims data.

By Maria Rachal • Aug. 18, 2020

FEMA pitches voluntary DPA pact to bolster medical supply chain during pandemic

The Defense Production Act allows private companies to enter agreements with the government while avoiding antitrust liability. AdvaMed wants to participate but FEMA has not yet extended an invite.

By Greg Slabodkin • Aug. 18, 2020

Thermo Fisher COVID-19 test flagged for false positive and negative results

An FDA alert on Monday follows a quarter in which coronavirus-related products added $1.3 billion to the medtech's sales, and after it scored an HHS contract to provide processing instruments to labs.

By Nick Paul Taylor • Aug. 18, 2020

FDA looks to downclass noninvasive bone growth stimulators, incumbents not on board

The agency made a case for moving the devices to less-rigorous Class II regulation in a proposal opposed by manufacturers with products already on the market such as Orthofix.

By Susan Kelly • Aug. 17, 2020