Medical Devices
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Permission granted by Pear Therapeutics
Pear more than doubles revenue from last quarter, shares new economic data
The company is keeping its 2022 revenue forecast of $22 million. Pear also presented economic data, which analysts said would be important in conversations with payers.
By Elise Reuter • May 17, 2022 -
Sarah Silbiger via Getty Images
Avanos Medical recall gets Class I label from FDA following patient injury, death reports
The company reported in a recall notice that there have been 60 injuries and 23 patient deaths associated with the Avanos Medical Cortrak 2 Enteral Access System since 2015, according to the FDA.
By Ricky Zipp • May 17, 2022 -
Trendline
The EU Medical Device Regulation
While the European Union’s MDR went into effect in May 2021, device makers still face a range of uncertainties and potential problems one year later.
By MedTech Dive staff -
Permission granted by Vicarious Surgical
Earnings week 4: Vicarious expects 2024 FDA filing for surgical robot; Steris reports record backlogs
Vicarious Surgical reaffirmed that it would not be making an FDA submission for its surgical robot until 2024, while Globus Medical and Steris discussed rising procedure volumes.
By Elise Reuter • May 16, 2022 -
Courtesy of Dexcom, Nick Jonas Super Bowl kit
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 -
Win McNamee/Staff via Getty Images
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 -
400tmax via Getty Images
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 • May 11, 2022 -
Carol Highsmith. (2005). "Apex Bldg." [Photo]. Retrieved from Wikimedia Commons.
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 -
Drew Angerer via Getty Images
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 -
Permission granted by Dexcom
Q&ADexcom 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 -
Stefan Zaklin via Getty Images
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 -
400tmax via Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
Permission granted by Insulet
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 -
Sasirin Pamai via Getty Images
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 -
Retrieved from The White House.
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 -
Courtesy of Boston Scientific
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 -
Андрей Клеменков via Getty Images
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 -
Brian Tucker
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 -
FURKAN TELLIOGLU via Getty Images
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 -
Stefan Zaklin via Getty Images
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
