Digital Health
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Google hires former FDA digital health officer to global strategy post
In his new role, Bakul Patel will help Google build a unified digital health and regulatory strategy.
By Samantha Liss • May 19, 2022 -
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 -
Explore the Trendline➔
Permission granted by Roy MendiolaTrendlineMedTech Dive Outlook 2022
The pandemic continues to disrupt the medical device industry early in 2022, as COVID-19 testing demand remains strong and nonemergent procedures are postponed. In this series, we look at the risks, challenges and opportunities ahead.
By MedTech Dive staff -
Sponsored by Esper
Building trust in new technology for remote patient care requires powerful device infrastructure
Here's what organizations need to know about building trust with patients for device-based care.
May 16, 2022 -
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 -
Q&A
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 -
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 -
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 -
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 -
"Oculus Quest II" by Maximilian Prandstatter is licensed under CC BY 2.0
Pear's VR product for postoperative pain granted FDA STeP designation
The agency's designation under the Safer Technologies Program for medical devices could expedite regulatory review for the virtual reality-based digital therapeutic, one of several products in Pear's pipeline.
By Elise Reuter • April 14, 2022 -
Digital health funding dropped in Q1 to lowest level since 2020: CB Insights
The report is directionally in line with the findings of an earlier report from Rock Health, which described how the drying up of deals in February and March may be an early sign of a correction in digital health venture capital funding.
By Nick Paul Taylor • April 14, 2022 -
Deep Dive
Can digital therapeutics become profitable?
As more software-based treatments gain FDA clearance, they still face hurdles ahead in getting insurance reimbursement and garnering adoption among patients and physicians.
By Elise Reuter • April 11, 2022 -
Medtronic's recall of over 175,000 MiniMed pumps labeled Class II by FDA
The recall, which will not require the retrieval of any devices, has been associated with serious injuries and one death, according to the company. Medtronic said an independent review did not attribute the death to the issue.
By Ricky Zipp • Updated April 8, 2022 -
iRhythm builds case for wearable cardiac monitor with data in fainting, TAVR patients
Data presented at ACC's Scientific Sessions show that by using iRhythm's Zio to monitor patients after discharge, physicians reduced hospital stays and potentially improved identification of arrhythmia.
By Nick Paul Taylor • April 4, 2022 -
Pear expects $22M in revenue this year, as it banks on growing adoption of digital therapeutics
Pear still has substantial challenges going forward, as it faces several unknowns about the long-term adoption and reimbursement of its products. The company has been operating at a net loss, seeing a $65 million loss last year.
By Elise Reuter • March 29, 2022 -
FDA asks Congress for 14% bump in device budget for supply chain, cybersecurity programs
For the devices program, the FDA is asking for roughly $698 million, with approximately $466 million from the budget authority and $232 million from user fees.
By Nick Paul Taylor • March 29, 2022 -
Google launches new search tool for provider appointments, seeks FDA approval for Fitbit feature
The tech giant is working to prop up its healthcare efforts following internal project shakiness that led the company to dismantle its Google Health business last year.
By Rebecca Pifer • March 28, 2022 -
Deep Dive
The case for hybrid care models
Telehealth is increasingly being woven into healthcare organizations' future plans, giving hope to proponents of hybrid care models.
By Rebecca Pifer • March 22, 2022 -
Dexcom's hospital glucose monitor leads latest FDA breakthrough designations
The regulatory privileges were granted to Dexcom after its at-home glucose monitors were allowed to be used in hospitals during the pandemic. AltPep, CardioStory, Insightec and Merit were also among the designations this month.
By Nick Paul Taylor • March 22, 2022 -
Sponsored by Medrio
Your consent can make or break your studies
Consent is a critical part of the patient journey, but ensuring patients are fully informed and willing to participate in a trial is an ongoing process. Discover best practices to achieve continuously informed consent.
March 21, 2022 -
What's holding up hospital at home?
Widespread adoption of acute-level care at home models has been hampered by physician reluctance and patchwork reimbursement, though a CMS waiver caused hospital participation to snowball during the pandemic.
By Rebecca Pifer • March 18, 2022 -
Q&A
'Not for the faint of heart': Insulet CEO talks Tandem and Medtronic competition, Omnipod 5 launch
Shacey Petrovic spoke to MedTech Dive about the long-awaited launch of its insulin pump, competitors' developing patch pumps and how the Ukraine crisis will impact the industry.
By Ricky Zipp • March 17, 2022 -
US replaces EU as priority market for medtech industry: survey
A survey of more than 100 executives at medical device companies found 89% of medtechs plan to prioritize U.S. regulatory approval going forward. One CEO said the EU's Medical Device Regulation "is killing innovation."
By Nick Paul Taylor • March 16, 2022 -
GE Healthcare profit forecasts meet estimates; spinoff details remain cloudy
While GE's planned spinoff of its healthcare unit in early 2023 remains on track, the company said business and regional segment details, stand-alone costs and capital structure have yet to be worked out.
By Greg Slabodkin • March 11, 2022 -
Akili plans to go public as it prepares to market video game treatment
"We've proven that foundation and now it's time to run and scale," CEO Eddie Martucci told MedTech Dive. The company is going public through a $1 billion SPAC, rather than a traditional IPO, which it expects to close in mid-2022.
By Elise Reuter • March 10, 2022 -
Q&A
Intuitive CEO on labor shortages, placements amid the pandemic, new competition
Gary Guthart spoke to MedTech Dive about facing new competitors Medtronic and Johnson & Johnson, and addressed criticism of the cost, safety and effectiveness of robotic surgery.
By Ricky Zipp • March 9, 2022