Coronavirus muddies FDA's trajectory on device warning letters

An agency official said going into 2020 that its devices center would be better equipped to use the compliance tool in a timely fashion. But a dry spell for on-site surveillance may undermine any noticeable rebound.

By Maria Rachal • Updated Aug. 12, 2020

FDA posts Essure adverse events pulled from social media

The spreadsheet includes details of 53 deaths and 1,376 reports of serious injuries related to the controversial birth control implant but the agency is unsure if it contains duplicate reports. 

By Nick Paul Taylor • Updated Aug. 14, 2020

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Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

BD's FDA filing to update recalled Alaris pumps delayed by 6 months

The medtech planned to rectify the situation with FDA this year, but that schedule has slipped as it continues system testing and ongoing discussions with the agency. BD estimates remediation costs will total $200 million.

By Greg Slabodkin • Aug. 10, 2020

Notified bodies list for incoming EU regs hits 20 with designation of DQS for MDR

The 16 notified bodies now allowed to complete work under the Medical Device Regulation and the four OK'd under its In Vitro Diagnostic counterpart together meet the goal that authorities had hoped to achieve by the start of 2020.

By Nick Paul Taylor • Aug. 10, 2020

10 states now on board to buy Quidel, BD antigen tests

With the latest additions of Arkansas and Rhode Island, there are now five Democratic and five Republican governors each planning to acquire half a million of the rapid point-of-care diagnostics from the medtechs.

By Greg Slabodkin • Updated Aug. 19, 2020

Medtronic, in catch-up to Axonics, wins nod for rechargeable bladder and bowel control device

After leading the sacral neuromodulation market for two decades, Medtronic is defending its turf with FDA approval of a product it contends is 80% smaller than its current device and 50% smaller than Axonics' rechargeable system.

By Susan Kelly • Aug. 4, 2020

CMS proposes eliminating inpatient-only list, in potential boon for ASCs

The agency would begin by removing about 300 musculoskeletal-related services, which could further accelerate ambulatory surgery centers' important role as medtech customers.

By Shannon Muchmore • Aug. 4, 2020

CMS pitches key telehealth changes following Trump executive order

In its 2021 physician fee schedule, the agency is proposing making permanent almost two dozen new telehealth codes and clarified certain provisions around remote patient monitoring.

By Rebecca Pifer • Aug. 4, 2020

J&J gets FDA breakthrough status for robot-assisted ablation device

The designation gives the product, which combines technologies Johnson & Johnson acquired via takeovers of NeuWave Medical and Auris Health, more regulatory support and potentially speedier review.

By Nick Paul Taylor • July 31, 2020

Falling FDA personnel costs soften 2021 medical device user fee hike

The agency's required user fees for medical device submissions will rise 7.2% beginning in October.

By Nick Paul Taylor • July 30, 2020

FDA finalizes guidance on multiple-function devices after industry feedback

The agency clarified its policies and regulatory practices governing devices that have at least one distinct function and one other purpose that is not subject to premarket review.

By Susan Kelly • July 29, 2020

Color targets supply, staffing bottlenecks with updated coronavirus test EUA

The population health technology company's test uses dry nasal swabs, eliminating the need for the viral transport media that's been in short supply and limited scaling by lab giants Quest and LabCorp.

By Nick Paul Taylor • July 28, 2020

Coronavirus testing hits a wall: Where do we go from here?

As LabCorp and Quest are backlogged in delivering molecular test results, some public health officials are calling for a shift in testing approach from slow and accurate to fast and good enough to meet demand.

By Greg Slabodkin • July 27, 2020

Medtech and COVID-19: 6 months into the public health emergency

MedTech Dive examines where the industry stands with testing and the future of those emergency use-authorized diagnostics, as well as how it's adapting to a rebound in elective surgeries and various supply chain challenges.

July 27, 2020

Diagnostics makers must plan for EUA products to have post-pandemic future

An extension to the public health emergency formalized a reprieve for emergency use authorizations, but manufacturers should act now if they want products to stay on the market when the crisis ends, compliance experts say.

By Greg Slabodkin • July 27, 2020

LabCorp COVID-19 test gets 1st FDA OK for asymptomatic screening

U.S. regulators simultaneously allowed the LabCorp test to be used in sample pooling, following the first such nod to a Quest Diagnostics test a week ago.

By Nick Paul Taylor • July 27, 2020

HHS renews COVID-19 public health emergency

The extension supported by AdvaMed, the American Clinical Laboratory Association and American Hospital Association takes effect Saturday and opens the door for FDA to keep issuing emergency use authorizations.

By Shannon Muchmore • July 23, 2020

4 healthcare sticking points as Congress weighs next coronavirus relief bill

Senate Republicans may limit allocations for testing efforts, as labs struggle to keep up with demand and return results in a timely enough fashion to leverage contact tracing.

By Rebecca Pifer , Samantha Liss • July 21, 2020

FDA eases rules on viral transport media to boost availability for COVID-19 testing

In some cases, a dearth of key materials has constricted efforts to widen COVID-19 testing. Now, the agency is allowing commercial manufacturers to ship products without filing a 510(k) or meeting UDI requirements.

By Nick Paul Taylor • July 21, 2020

Quest coronavirus test becomes 1st with FDA OK for sample pooling

The technique is "not a magic bullet," Quest's chief medical officer said, with demand for its COVID-19 services still overwhelming capacity. However, rival LabCorp said it has reduced its average turnaround time for results.

By Maria Rachal • July 20, 2020

3 Quest COVID-19 assays get FDA OK for at-home collection via telehealth

The agency this week granted new emergency use authorizations to three tests, previously granted EUAs, so users can self-collect nasal swab samples while being observed by a healthcare provider remotely.

By Greg Slabodkin • July 17, 2020

Ambu wins FDA clearance for single-use duodenoscope product

Boston Scientific was first to obtain an agency nod for a fully disposable version, meant to be safer against infection, which it believes could be worth more than $1 billion.

By Maria Rachal • July 17, 2020

UK signals Stryker offer to unload ankle replacement product could clear Wright Medical buy

The medtech giant's proposed $4 billion acquisition prompted competition concerns among regulators. Stryker disclosed in a filing Wednesday it pitched divesting its STAR product line, which may satisfy U.K. authorities.

By Greg Slabodkin • July 15, 2020

FDA commits to staggered move to electronic medtech filings

Finalized guidance on electronic submissions of medical device regulatory filings takes into account AdvaMed comments on timing.  

By Nick Paul Taylor • July 15, 2020

FDA proposes BPH device trial guidance changes as market heats up

The updates come as a swath of companies take aim at the benign prostatic hyperplasia opportunity, which medtechs like Boston Scientific and Teleflex have invested in more since FDA issued development guidance a decade ago.

By Nick Paul Taylor • July 14, 2020