Medical Devices: Page 76
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Permission granted by Pear Therapeutics
Pear sets out payer strategy as it seeks to quadruple prescriptions of digital therapeutics
Pear shared real-world data that linked its digital therapeutic for substance use disorder to an estimated $3,591 reduction in per-patient costs.
By Nick Paul Taylor • June 7, 2022 -
Courtesy of Abbott
Abbott, Medtronic make case for key diabetes products in ADA presentations
Researchers at Abbott Laboratories used the event to highlight data on the FreeStyle Libre 3 continuous glucose monitor, while Medtronic arrived at the sessions with real-world results on the MiniMed 780G insulin pump.
By Nick Paul Taylor • June 6, 2022 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical 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 -
Sarah Silbiger via Getty Images
Getinge's recall of 69,000 stents labeled as Class I event by FDA amid complaints, injuries
The recall relates to the separation of the balloon or catheter hub during the removal of the delivery system from the patient.
By Nick Paul Taylor • June 3, 2022 -
Medtronic
Medtronic expects diabetes unit's struggles to continue as rivals grow sales, launch products
The company forecasts revenues for the diabetes business to decrease 8% to 10% in the first quarter of its fiscal year and 6% to 7% for the full year.
By Ricky Zipp • June 1, 2022 -
Photo illustration by Danielle Ternes/MedTech Dive; photograph by spainter_vfx via Getty Images
BD's Pyxis medication dispenser gets fifth DHS cybersecurity alert in 5 years
The company said there are no known public exploits that specifically target a password vulnerability and that it's working to address the problem.
By Nick Paul Taylor • June 1, 2022 -
Sarah Silbiger via Getty Images
Recalled devices surged in first quarter, driven by BD connectors
A recall of 288 million Becton Dickinson connectors for catheter ports drove up the total number of recalled devices in the quarter. Mislabeling was the top reason for FDA alerts over the three-month period, a Sedgwick report found.
By Nick Paul Taylor • June 1, 2022 -
Courtesy of Boston Scientific
Boston Scientific would be 'good fit' for increasingly acquisitive J&J, analysts say
A limited portfolio overlap could make Boston Scientific a target should Johnson & Johnson's CEO seek a large medtech acquisition.
By Nick Paul Taylor • May 31, 2022 -
Courtesy of Abbott
Abbott's Libre 3 glucose monitor gets FDA clearance as CGM market intensifies
The 14-day glucose sensor is smaller and thinner than its predecessor, and will give Abbott a head start on rival Dexcom’s newest continuous glucose monitor.
By Nick Paul Taylor • May 31, 2022 -
Courtesy of Abbott
Abbott's imaging catheter recall gets Class I label from FDA over vascular injury risks
The proximal markers in the Dragonfly OpStar Imaging Catheters can become loose and separate from the device while in use.
By Nick Paul Taylor • May 27, 2022 -
Medtronic expects supply chain issues to continue after 'catastrophic explosion' last quarter
The company expects revenue to be down 4.5% to 5.5% next quarter, assuming no near-term improvement in the supply chain.
By Elise Reuter • Updated May 27, 2022 -
Sascha Schuermann via Getty Images
Baxter raises forecasts for Hillrom synergies, allaying concerns over $10.5B takeover
Company executives said the additional cost savings emerged as they took a closer look at Hillrom’s real estate footprint.
By Nick Paul Taylor • May 26, 2022 -
Getty
Verily advances smartwatch toward Parkinson's clinical trial use after validating technology
The researchers concluded the wearable device could reduce the sample size needed to show the effect of a therapeutic intervention.
By Nick Paul Taylor • May 25, 2022 -
How a Dexcom-Insulet combination would shake up the diabetes treatment industry
Following a Bloomberg News report that Dexcom is in talks to buy Insulet, analysts say such a move would put competitors in a "tough spot."
By Ricky Zipp • May 25, 2022 -
atiatiati via Getty Images
Medtech companies keep supply, staffing challenges in check even as recession risks loom: analysts
Companies are coping with factors such as supply disruptions, staffing shortages, inflation and foreign-exchange hurdles, according to William Blair analysts.
By Nick Paul Taylor • May 24, 2022 -
Courtesy of Dexcom, Nick Jonas Super Bowl kit
Dexcom says it's not in acquisition talks
Bloomberg News reported last week that the company was seeking to buy Insulet.
By Ricky Zipp • Updated May 31, 2022 -
VCG / Stringer via Getty Images
Appeals court sides with Intuitive over J&J in surgical device patent disputes
A successful appeal by Ethicon would have affected imports of Intuitive Surgical’s SureForm staplers and associated reload cartridges.
By Nick Paul Taylor • May 24, 2022 -
Permission granted by OptimizeRx
Sponsored by OptimizeRxAI and RWD in HCP engagement – here's the secret to effective execution
Rethink your approach to AI and RWD and turn ideas into actionable strategies for medtech marketers.
May 23, 2022 -
Edwards posts 97% success rate with tricuspid device in 30-day test as it prepares for Abbott rival
Edwards' device posted a 97% implant success rate, while Abbott's had a 98% success rate. Both are part of a growing market for transcatheter valve repair devices.
By Nick Paul Taylor • May 20, 2022 -
FDA gets over 21,000 medical device reports, including 124 deaths, linked to Philips foam breakdown
The medical device reports were made between April 2021 and April 2022. Both Philips and the FDA contend that the reporting system has limitations, including the underreporting of events and inaccuracies of reports.
By Ricky Zipp • May 20, 2022 -
Megan Quinn/MedTech Dive
FDA user-fee bill goes to House; Senate committee draft revamps diagnostic regulations
The House Energy and Commerce Committee unanimously passed a bill to reauthorize the FDA’s user-fee amendments for the next five years. A Senate committee draft of the bill would add substantive changes.
By Elise Reuter • May 19, 2022 -
Courtesy of Boston Scientific
Study shows that Abbott's Amulet, Boston Scientific's Watchman devices are riskier for women
The analysis builds on previous studies showing that left atrial appendage occlusion devices are riskier for women. However, Abbott's recent study shows comparable outcomes for men and women at 18 months.
By Nick Paul Taylor • May 19, 2022 -
Medtronic links renal denervation to increased time below blood-pressure threshold
Results from two studies come after the medtech company had a setback in renal denervation in October. Medtronic is expected to report results from its pivotal trial this year.
By Nick Paul Taylor • May 18, 2022 -
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 -
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
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