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Deep Dive

5 ways COVID-19 is reshaping the medtech industry

Remote tech, clinical trials and marketing are a few of the areas disrupted by the pandemic this year — with changes that look set to stick around.

Digital health funding this year already at record high $9.4B, Rock Health says

Telemedicine and other on-demand services were particularly active as the COVID-19 pandemic drove consumer interest in those areas.

Abbott, on defense, details embattled rapid COVID-19 test results

New data on the ID Now product comes amid criticism that the White House leaned too heavily on the quick-turnaround diagnostic, in light of President Donald Trump's illness and widespread West Wing infection.

Steris inks $850M deal for Key Surgical adds to medtech M&A wave

CEO Walter Rosebrough gave a nod to current low interest rates but said Steris had been looking at this potential transaction "for years, not months."

App-connected pacemakers, telehealth among Cleveland Clinic top 2021 innovations

Medtronic's MyCareLink Heart pacemaker smartphone app is one example of the four medtech developments making the annual top 10 list of medical breakthroughs.

Analysts predict Zimmer Biomet M&A in 2021 to speed growth

The medtech is likely to initially target private orthopaedic companies worth up to $300 million, Needham analysts specified. The spine and dental businesses, meanwhile, could be on the chopping block.

CMS officials elaborate on proposed breakthrough device coverage pathway

Agency representatives fleshed out details of proposed reimbursement meant to speed coverage of these technologies in a townhall webcast during AdvaMed's Virtual MedTech Conference.

M&A on horizon as deep-pocketed medtechs eye distressed assets: EY

The combination of smaller companies questioning their pandemic survival and larger companies with considerable capital may spark a buying surge, the consultancy said in its annual medtech report.

Medical Alley, GI docs push to ease CMS device pass-through payments

The trade group for Medtronic, Boston Scientific and other medtech giants wants to bar Medicare contractors from making regional coverage decisions that obstruct transitional pass-through payments.

Ex-FDA chief Gottlieb questions White House reliance on Abbott COVID-19 test amid Trump diagnosis

"The Cepheid GeneXpert probably would be more fit to purpose. But, frankly, you'd need double layers of testing," President Donald Trump's former agency head said in a television appearance Sunday.

Amid pandemic, specialty telehealth outpaces urgent care, Amwell poll says

Willingness to use virtual care notably doubled in a handful of high-volume fields like radiology, cardiology and surgery, the survey found.

Quidel antigen test to detect COVID-19 and flu gets FDA nod

While Roche, Cepheid and LabCorp are among the companies offering combination tests, Quidel is the first to sell a fast-turnaround antigen-based option.

Smith & Nephew, Quidel forecasts may signal improving ortho, diagnostics markets

The preliminary Q3 results are a positive sign for elective surgery volumes at other orthopaedics competitors such as J&J and Stryker and for COVID-19 antigen testing businesses including Abbott and BD.

Invitae cash-and-stock buyout of ArcherDX a done deal

The medical genetic testing company swept in after the assay developer announced plans to go public. Invitae will now offer tests for more stages of cancer care, from assessing disease risk to monitoring its progression.

UPDATED: Oct. 5, 2020 at 10:18 a.m.

Ethylene oxide sterilizer rule pushed back by EPA

FDA held a related advisory panel late last year, where one member said the shutdown of device sterilization plants put the U.S. "on the cusp of a major medical logistical failure." COVID-19 has shifted the landscape.

AdvaMed sends CMS reform wishlist to boost digital health device coverage

The medtech industry group argues changes are needed for Medicare to realize the potential of a sector projected to be worth $500 billion by 2026.

FDA flags risk of infection with CardioQuip heater-cooler device

The alert comes after three patients were infected with mycobacteria. All such devices on the U.S. market have now been implicated in contamination, including those made by LivaNova, Cincinnati Sub-Zero, Maquet and Terumo.

UPDATED: Oct. 1, 2020 at 5:03 p.m.

Medtronic hit with DOJ ventilator antitrust probe

The investigation comes amid allegations that industry consolidation contributed to a shortage of the breathing devices during the early months of the COVID-19 pandemic.   

COVID-19 spurred a medtech M&A boom this summer. Will it last?

Siemens Healthineers' CEO was rebuffed by his counterpart at Varian in January. But come May, the impact of coronavirus began to become clear. 

AtriCure stock recovers after short seller predicts 'complete collapse' of business

Shares in the atrial fibrillation medtech were down 14% immediately following a scathing report. Analysts at SVB Leerink rebutted the grim assessment from Kerrisdale Capital.

Medtronic to expand dialysis access position with Avenu Medical buyout

The deal is the second tuck-in acquisition this year for the medtech's peripheral vascular business and the company's sixth overall, following additions to insulin delivery, surgery and spinal cord stimulation offerings.

UPDATED: Sept. 30, 2020 at 2:29 p.m.

Analysis of FDA safety alerts spurs call for changes to medical device adverse event reporting

Slow implementation of UDI and NEST are among the hangups prompting JAMA Internal Medicine authors to envision a better U.S. system for tracking and identifying adverse events, including more mandatory reporting.

Smith & Nephew inks $240M deal to buy orthopaedic assets from Integra

The U.K.-based medtech will gain control of a portfolio of shoulder replacement products and other devices that generated revenues of $90 million last year.

6.5M Abbott COVID-19 antigen tests to reach states this week

Initial distribution of the rapid point-of-care diagnostics is meant to help reopen economies and schools, President Donald Trump said. It's still far short of the 200 million some experts say are needed each month.

Stryker stretches Wright Medical share offer into Q4

As the medtech makes the fifth offer extension since the $4 billion acquisition was announced last November, the company is approaching the latest time it said the deal would close.

UPDATED: Sept. 29, 2020 at 11:32 a.m.