Deep Dive
Industry insights from our journalists
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Emily Olsen/MedTech Dive
AI could be a game changer, but healthcare needs to be ‘exceedingly careful’
Artificial intelligence tools could help solve workforce challenges. Implementation, however, can be difficult, pushing organizations to consider less risky administrative and back-office tasks first.
Emily Olsen • Oct. 29, 2024 -
5 steps to navigate the FDA’s new lab developed test rule
Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five strategies labs can take to be ready.
Susan Kelly • Oct. 21, 2024 -
Daniel Karmann/Picture-Alliance/DPA/AP
The number of AI medical devices has spiked in the past decade
The FDA has authorized nearly 1,000 medical devices with artificial intelligence features as companies including GE Healthcare and Siemens Healthineers build out their AI efforts.
Elise Reuter and Jasmine Ye Han • Oct. 9, 2024 -
Scott Olson/Getty Images via Getty Images
4 steps to minimize the threat of legacy medical devices
Older medical devices with unsupported software pose cybersecurity threats that regulators and industry are struggling to solve. Here are four steps experts say can help mitigate risks.
Ricky Zipp • Sept. 23, 2024 -
Ryan David Brown/Getty Images via Getty Images
Medtech firms have cut more than 14,000 jobs in the past 18 months
Diagnostics is the largest industry represented in the data, with more than 5,000 affected positions, according to MedTech Dive’s analysis.
Jasmine Ye Han, Ricky Zipp and Elise Reuter • Updated July 25, 2024 -
Anna Moneymaker / Staff via Getty Images
FDA’s lab developed test rule could be first check on agency’s power post-Chevron
The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.
Susan Kelly and Elise Reuter • July 11, 2024 -
Permission granted by Nextbeam
EtO causes cancer. Device sterilizers are scrambling to find alternatives.
No one solution can match the scope and scale of ethylene oxide, but a “multi-pronged approach” can help reduce emissions, an FDA official said.
Elise Reuter • May 6, 2024 -
Techa Tungateja via Getty Images
As cyberattacks on healthcare persist, can the FDA’s new device regs hold up?
Revamped regulations to thwart hackers are a big step forward, but issues such as legacy devices and reliance on software patches pose lingering challenges.
Ricky Zipp • April 3, 2024 -
N/A via Getty Images
6 ways the FDA can improve medical device recalls
Experts said improving how adverse events are tracked and requiring manufacturers to use electronic notifications could make devices safer.
Elise Reuter • March 18, 2024 -
Julia Rendleman via Getty Images
Why Cigna is capping cost increases for pricey GLP-1 weight loss drugs
The first-of-its-kind move comes as pharmacy benefit managers continue to try to prove their value to clients, and shows how major players are shoring up to meet sky-high GLP-1 demand.
Rebecca Pifer • March 11, 2024 -
Jolygon via Getty Images
4 heart device trends shaping the medtech sector in 2024
Medtronic, Boston Scientific and J&J are among the medtech companies advancing treatments in cardiac care for when medicines are not enough.
Susan Kelly • Jan. 30, 2024 -
real444 via Getty Images
Orthopedics leaders watch procedure backlog, new technologies in 2024
J&J, Medtronic and Smith & Nephew executives and orthopedic surgeons said they expect more procedures to move outpatient, while questions about pricing and procedure backlogs loom over the medical technology industry.
Elise Reuter • Jan. 23, 2024 -
Courtesy of Boston Scientific
5 medtech trends to watch in 2024
From the M&A outlook and tough year-over-year comparisons to emerging markets like pulsed field ablation, here are the top medical technology trends to watch this year.
Ricky Zipp • Jan. 9, 2024 -
Photo illustration: Shaun Lucas/Industry Dive; CRISPR Therapeutics; Gregor Fischer/DPA/Newscom
‘No tolerance for failure’: An oral history of the first CRISPR medicine
A new sickle cell disease therapy developed by CRISPR Therapeutics and Vertex Pharmaceuticals is now approved in the U.S. and U.K. This is the story of how it came to be.
Ned Pagliarulo and Shaun Lucas • Dec. 13, 2023 -
Matt Rourke/AP
Why medical device companies are worried about the EPA’s planned sterilization regs
The EPA is expected to finalize new regulations in March that would limit ethylene oxide emissions from companies that sterilize medical devices.
Elise Reuter and Shaun Lucas • Nov. 27, 2023 -
Ethan Miller via Getty Images
Why medtech firms are putting diabetes tech in consumer devices
As Abbott develops a line of wearable wellness devices, and Dexcom makes a CGM for people with diabetes who don’t take insulin, both companies are turning to new users for future growth.
Elise Reuter • Updated Aug. 31, 2023 -
Courtesy of Dexcom
Dexcom, Abbott ramp up DTC marketing amid fight for share of growing diabetes market
As insurers cover continuous glucose monitors for more people, device-makers are taking a page from the pharma marketing playbook.
Elise Reuter • Aug. 17, 2023 -
Courtesy of BusinessWire/Masimo
Showdown at Masimo: Proxy battle targets CEO Kiani’s leadership, board
Shareholders are voting on whether to add investor Politan Capital’s picks to the board of the pulse oximeter maker, a move that could change the company’s direction.
Susan Kelly • June 23, 2023 -
Permission granted by Tidepool
Grassroots innovation: How a patient-driven device for diabetes won FDA clearance
Tidepool Loop, an automated insulin dosing app based on one developed by the DIY diabetes community, received FDA clearance in January.
Elise Reuter • April 3, 2023 -
webphotographeer via Getty Images
Delays in reporting led FDA to late cancer warning on breast implants, advocates say
Cases need to be better tracked, and the cancer risks should be discussed with patients prior to surgery, patient advocates and physicians said.
Elise Reuter • March 22, 2023 -
Volodymyr Bushmelov via Getty Images
Diabetes outlook: What Dexcom, Medtronic and other leaders are watching in 2023
From new product launches to regulatory changes that could expand CGM coverage, company executives and analysts share their predictions.
Elise Reuter • Jan. 20, 2023 -
ryasick via Getty Images
A look back at medtech’s top 10 acquisitions of 2022
While larger acquisitions were announced at the end of the year including J&J’s $16.6B purchase of Abiomed, the number of deals declined from 2021.
Elise Reuter • Dec. 22, 2022 -
Courtesy of Masimo
Apple locked in court battles with small medtech firms over allegations of stolen technology
AliveCor and Masimo are looking to bar Apple from selling watches that use technology the firms claim they invented.
Elise Reuter and Nick Paul Taylor • Updated Dec. 13, 2022 -
Kena Betancur via Getty Images
Health tech companies weigh options to stem cash burn as IPO market sags
Healthcare technology companies are delaying initial share sales as public market stocks and valuations plunge across the sector. Where will they turn in the meantime?
Sydney Halleman • Updated Nov. 24, 2022 -
Permission granted by Stryker
Medtech companies shift strategy as more orthopedic procedures move to ambulatory surgical centers
Many ASCs are looking for cashless options to get capital equipment as they offset the cost of new buildings, Zimmer Biomet COO Ivan Tornos said.
Elise Reuter • Oct. 5, 2022
