Dexcom, Insulet, Tandem start 2022 with revenue growth after weathering omicron surge

All three diabetes technology companies reported that omicron pressured business in January before easing as the quarter progressed.

By Ricky Zipp • May 13, 2022

House subcommittee debates device remanufacturing definition, sends user-fees bill to next stage

Members of the House Subcommittee on Health passed the user-fees bill by a vote of 30-0 Wednesday, sending the legislation to the full House Committee on Energy and Commerce.

By Elise Reuter • May 12, 2022

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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

Roundup: As procedures rebound, supply chain, staffing challenges set to continue for medtechs

Procedure-driven companies saw sales recover at the end of the first quarter, while diagnostics businesses reported increased sales of COVID-19 tests due to the omicron surge in January.

By Elise Reuter • Updated May 19, 2022

Medtronic completes Intersect acquisition following FTC order

The Federal Trade Commission required Medtronic to divest a subsidiary of Intersect ENT to complete the deal. Medtronic announced the $1.1 billion acquisition last August.

By Nick Paul Taylor • Updated May 16, 2022

Rising Google searches for procedures suggest recovering demand at medtechs: analysts

Google searches for nonemergent procedures are above pre-pandemic levels, providing another data point to indicate that demand is recovering, according to a Needham report.

By Nick Paul Taylor • May 11, 2022

Dexcom Chief Tech Officer Leach discusses G7's European launch and FDA review, expanding Dexcom One

The executive also comments on the continuous glucose monitor maker's next steps for the G7 system as well as its plans for reaching new patients and expanding to non-diabetic users.

By Ricky Zipp • May 10, 2022

House user-fees bill details clinical trial diversity, cybersecurity requirements

The legislation would let the FDA bring in $1.78 billion in fee revenue from 2023 to 2027 to fund the review of medical devices. That amount could increase to $1.9 billion if the agency meets certain performance goals.

By Elise Reuter • May 10, 2022

Earnings week 3: Procedure rebounds, stock price declines, iRhythm's comeback

AtriCure and Axonics reported procedure volume rebounds and both firms increased their 2022 forecasts. Still, the share prices of the companies dropped late last week.

By Ricky Zipp • May 9, 2022

FDA finalizes guidance on clinical feasibility studies of diabetic glycemic control devices

The recommendations come amid an increase in requests for feedback from developers of diabetes devices.

By Nick Paul Taylor • May 9, 2022

Insulet CEO Petrovic to step down on June 1 due to personal reasons; Hollingshead named sucesssor

Shacey Petrovic, who has served as CEO since 2019, is resigning in the first months of the Omnipod 5 launch, an anticipated product for the diabetes tech space. Jim Hollingshead, an Insulet board member since 2019, will take over.

By Ricky Zipp • May 6, 2022

Ortho revenue rebounds in Q1 even amid 'tough' start, labor shortages

Some companies posted sales in the period that matched or surpassed pre-pandemic levels.

By Elise Reuter • May 5, 2022

Biden should send 'clear' message to semiconductor industry on prioritizing medtech, AdvaMed says

The trade group said it's pushing for the prioritization of medtechs, transparency for future allocations to the industry, and actions to ensure the continuity of patient care in the U.S.

By Nick Paul Taylor • May 4, 2022

Boston Scientific's Watchman FLX shows higher success rate than predecessor, boosting Abbott rivalry

Watchman FLX is associated with fewer major adverse events and higher rates of success than its predecessor, according to an analysis of registry data. The study builds on Boston Scientific's new rivalry with Abbott's Amulet device.

By Nick Paul Taylor • May 4, 2022

CDRH proposes requirement for Philips to submit recall plan for sleep-apnea, ventilator devices

The order would mean Philips would have to submit a plan to repair or replace the device or refund customers.

By Elise Reuter • May 3, 2022

Earnings week 2: Supply chain shortages slowed ResMed, other medtechs from meeting demand

Philips and ResMed were among several medtechs that listed supply chain shortages as a challenge in earnings calls.

By Elise Reuter • May 2, 2022

CDRH's Shuren expects center to return to normal this year despite ongoing COVID work

Jeff Shuren, the director of the FDA's Center for Devices and Radiological Health, also stressed the need for increased cybersecurity and supply chain funding and authority during an event on April 29.

By Ricky Zipp • May 2, 2022

GE Healthcare, Medtronic turn to outpatient care in new partnership

The companies agreed to a collaboration on ambulatory surgery centers and office-based labs as more procedures are shifting to outpatient care settings. 

By Elise Reuter • April 29, 2022

Medtronic, FDA warn providers of HVAD pump malfunctions nearly 1 year after pulled from market

Medtronic said in a letter to healthcare providers that three patients had pumps exchanged due to malfunctions; two of them died following the swap outs.

By Ricky Zipp • April 29, 2022

Medtronic's Covidien has another Class I recall for PB980 ventilators

The event adds to Medtronic’s ongoing product safety issues. In January, CEO Geoff Martha said addressing recalls and patient safety were a “top priority.”

By Ricky Zipp • April 28, 2022

Edwards sees boost in TAVR volumes; CEO says hospitals 'still recovering' from the pandemic

The company's U.S. sales for transcatheter aortic valve replacement devices increased by 10% year over year, estimating a similar jump in procedures.

By Elise Reuter • April 27, 2022

FDA comes under fire at Senate hearing for lack of MDUFA accountability, transparency

"The agency didn’t meet all its goals from the last time around. And now, the FDA wants double the money for mediocre performance improvements and, for certain devices, longer review times," said Sen. Richard Burr, R-N.C.

By Greg Slabodkin • April 27, 2022

Boston Scientific expects more stable 2022 as procedure volumes recover

CEO Michael Mahoney told investors during a first-quarter earnings call the medtech doesn't anticipate as volatile a year as 2021 as most regions are recovering from the pandemic.

By Ricky Zipp • April 27, 2022

GE Healthcare hit by supply chain constraints, inflation pressures

"We're operating in a challenging macro environment," GE CEO Larry Culp said during a first-quarter earnings call, while also noting COVID-19 lockdowns in China and lower sales volumes in Russia and Ukraine impacted results. 

By Greg Slabodkin • April 26, 2022

HHS inspector general rules physician-owned device company poses a low risk of fraud and abuse

Ropes & Gray, the law firm that represented the physicians in the advisory opinion process, said the ruling may benefit medical device innovators that have been shut out of hospitals because they have physician owners.

By Nick Paul Taylor • April 26, 2022

Philips commits more cash to recall as DOJ issues subpoena

The Dutch conglomerate said Monday that it is cooperating with an April 8 subpoena from the U.S. Department of Justice seeking information related to the Respironics recall of sleep apnea devices and ventilators.

By Nick Paul Taylor • April 25, 2022