CDRH still digging out of backlog caused by COVID-19: Shuren

"We think it's more important to focus on the submissions we already have in house than to talk about products yet to come before us," the device center chief said. "Hopefully, sometime in 2022 we'll get back on track."

By Ricky Zipp • July 22, 2021

FDA seeks funds, powers to fix 'great weaknesses' in medical device supply chain

Acting FDA Commissioner Janet Woodcock wants Congress to give the agency "expanded authority to obtain supply disruption notifications for critical devices any time there is the potential for a shortage."

By Nick Paul Taylor • July 22, 2021

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

J&J medical device sales return to pre-pandemic levels in Q2 as COVID-19 impact wanes

The company's return to growth, fueled by the recovery of elective volumes, could signal where procedure-dependent medtechs stand as the industry recovers from the effects of the coronavirus.

By Ricky Zipp • July 21, 2021

Radiation therapy 'under attack' from CMS cuts, professional body warns

Equipment manufacturers including Varian, ViewRay, Hitachi, Siemens and Elekta are among those that could also be affected by the reimbursement changes.

By Nick Paul Taylor • July 21, 2021

CMS pitches stiffening price transparency fines, halting end of inpatient-only list

The proposed rule moves hundreds of procedures back to hospitals and reverses a Trump-era regulation that attempted to phase out the inpatient-only list. An ASC representative called the regulatory back-and-forth "jarring."

By Shannon Muchmore • July 20, 2021

Nevro gets FDA nod for diabetic neuropathy treatment but misses Q2 sales target

The agency's OK for the spinal cord stimulation device potentially opens a market worth billions of dollars. For now, though, preliminary quarterly revenue came in below its prior forecast.

By Nick Paul Taylor • July 20, 2021

NuVasive's scoliosis system gets reinstated CE mark, new instructions for use

FDA said in a Friday safety communication that NuVasive has also lifted a shipping hold for MAGEC systems outside of the U.S. The company lifted a U.S. shipping hold in July.

By Nick Paul Taylor , Ricky Zipp • Updated Dec. 13, 2021

FDA grants Curative request to revoke COVID-19 test EUA, company pivots to Abbott kits after false result risk

The agency, which announced the revocation on Thursday, originally granted an emergency use authorization to Curative's test in April 2020. By January, FDA had concerns about false results potentially linked to sample collection.

By Nick Paul Taylor • July 16, 2021

Dexcom wins FDA nod for real-time APIs, allowing third-party developers access to CGM data

Teladoc Health's Livongo and smartwatch maker Garmin are in the testing and development phase, Dexcom said. The clearance comes as FDA is working to address the devices backlog created by the pandemic.

By Ricky Zipp • July 16, 2021

Kiwa Cermet Italia becomes 21st notified body under MDR amid capacity concerns

It is the first new NB since May's date of application and the fourth organization to be designated this year. But, MedTech Europe has warned about limited certification capacity as thousands of certificates are set to expire before 2024.

By Nick Paul Taylor • July 15, 2021

Transmedics wins premarket approval for OCS liver system, adding to recent FDA nods

The company was granted premarket approval for the OCS heart system and 510(k) clearance for the OCS lung solution. Transmedics' stock price was up over 6% following the Wednesday announcement.

By Nick Paul Taylor • Updated Sept. 29, 2021

CMS proposes extension of Medicare telehealth coverage

Provider groups are not happy with the payment adjustment in the rule — a 3.75% reduction to the conversion factor due to budget neutrality requirements — and will likely seek congressional intervention.

By Shannon Muchmore • July 14, 2021

CMS again passes on national pricing for long-term cardiac monitoring, dramatically reduced rates remain

The Physician Fee Schedule proposal continues the seven-month pricing saga that has hung over the cardiac wearables sub-market. Companies like iRhythm now have few options left to get substantially reduced rates increased.

By Ricky Zipp • July 14, 2021

TransMedics stock halted in Nasdaq trading ahead of FDA advisory panel meeting

The company's stock price was down more than 5% at the close of trading on Tuesday. An FDA panel on Wednesday is evaluating data concerning the safety and effectiveness of TransMedics' device for preserving donor livers.

By Nick Paul Taylor • Updated July 14, 2021

Medtech pay to doctors plunged in 2020 as COVID-19 pummeled electives, in-person services fell

Zimmer Biomet had the biggest drop, cutting general payments nearly 80% to $63 million. Other notable decreases include Stryker, J&J's DePuy Synthes and Boston Scientific.

By Ricky Zipp • July 12, 2021

Hillrom ordered to complete BardyDx transaction by Delaware court

The court found recent Medicare rate cuts for long-term cardiac wearables did not qualify as a material adverse event, siding with Bardy Diagnostics. However, the judge did not grant BardyDx compensatory damages.

By Ricky Zipp • July 12, 2021

MDUFA talks expose 'fundamentally different' views of FDA and device companies

At the latest meeting over user fees, industry remained opposed to the agency's pitch for a Total Product Life Cycle Advisory Program, which it contends would extend the scope beyond FDA's purview. 

By Nick Paul Taylor • July 12, 2021

Abbott's Alere settles with DOJ for $38.75M over defective coagulation test allegations

The Justice Department accused Alere of concealing the defect for years despite knowing the tests were linked to over a dozen deaths and hundreds of injuries. Abbott noted the product was discontinued and never sold by the company.

By Nick Paul Taylor • Updated July 13, 2021

Biden order takes aim at high cost of hearing aids, calls for OTC sales

The executive order issued Friday directs HHS to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter. 

By Samantha Liss • Updated July 12, 2021

FDA flags biocompatibility concerns linked to NuVasive's Precice devices

The agency is recommending physicians stop implanting new stainless steel devices. NuVasive voluntarily removed the products from the U.S. market in February.

By Nick Paul Taylor • July 9, 2021

Quidel COVID-19 PCR recall dubbed Class I by FDA due to false negative risk

The diagnostic company said it worked with FDA to confirm "a rare potential" for false test results and that the notice alerts lab customers of label changes made two months ago with no products removed from shelves.

By Nick Paul Taylor • Updated July 9, 2021

EU experts challenge notified body in first opinion on clinical evidence under MDR

The independent panel wants to see an extended study with at least another four months of data on the Class III implantable xenogeneic bone graft. This is the first real-world look at the scrutiny process mandated by the new rules.

By Nick Paul Taylor • July 7, 2021

FDA finalizes guidance on form, content of unique device identifiers

The final text responds to, but in some cases holds firm against, concerns raised by groups including AdvaMed about the 2016 draft and also adds a new section on standalone software.

By Nick Paul Taylor • July 7, 2021

As EU-wide health technology oversight law nears passage, industry is not pleased

If passed, the legislation mandates European Union clinical assessments of certain medical devices to inform national-level pricing and reimbursement decisions.

By Nick Paul Taylor • July 6, 2021

Dexcom CEO on the Type 2 population, the Super Bowl ad and pandemic momentum

Kevin Sayer called Type 2 a "tremendous market opportunity" and said direct-to-consumer advertising is worth some controversy.

By Ricky Zipp • July 6, 2021