The Latest
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Courtesy of Inflammatix
Inflammatix raises $57M to advance test for infection, sepsis
Inflammatix has now raised over $200 million in private capital, in addition to more than $50 million in grants and contracts.
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Permission granted by Roche
Roche to launch new CGM in Europe in ‘coming weeks’
Roche will roll out its Accu-Chek Smartguide in the Netherlands, Switzerland and Germany. The company hopes to stand out from competitors with features to predict hypoglycemia.
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Sarah Silbiger via Getty Images
FDA warns 2 Chinese labs for oversight failures, animal care violations
The FDA said the problems “raise concerns about the quality and integrity of data generated by the labs,” which provide third-party testing and validation data services for device firms.
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FangXiaNuo via Getty Images
SS Innovations expects US OK for surgical robot in 2025
The robot maker plans to conduct clinical trials for several indications, including abdominal, pelvic, thoracic and cardiac procedures.
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Sarah Silbiger via Getty Images
FDA to investigate presence of metals in tampons
Members of the Democratic Women’s Caucus last week urged FDA Commissioner Robert Califf to address the safety concerns.
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Courtesy of Spectrawave
J&J leads $50M financing for imaging company Spectrawave
The Series B round will support commercial expansion and product additions for Spectrawave’s system used in the treatment of coronary artery disease.
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Permission granted by Abbott
Dexcom, Abbott OTC glucose sensors add to busy year for diabetes tech
New over-the-counter sensors, an Abbott-Medtronic partnership and Roche’s first CGM are among diabetes technology’s top stories so far in 2024. Check out MedTech Dive’s roundup of the latest news.
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Justin Sullivan via Getty Images
Apple adding sleep apnea feature to smartwatch
Apple unveiled the health feature alongside new hearing aid capabilities for its Airpods Pro 2 earbuds.
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Sarah Silbiger via Getty Images
Smiths Medical links 1 death, 35 injuries to defective airway tubes
Vivek Jain, CEO of parent ICU Medical, recently told investors the company has faced more challenges than expected when it bought the Smiths medical device business in 2022.
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Adene Sanchez via Getty Images
Lab group urges lawmakers to rescind FDA final rule on LDTs
A survey found 48% of labs will discontinue LDTs if they do not qualify for an exception under the FDA final rule.
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the rads via Getty Images
Many FDA-authorized AI devices lack validation data
About 43% of all AI-enabled devices cleared or approved by the FDA through 2022 were missing validation data, and only 28% were tested prospectively, according to a Nature Medicine study.
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Samuel Corum via Getty Images
Illumina court ruling limits EU regulators’ merger review power
The European Commission lacked oversight authority to examine the proposed sale of a cancer-detection company to biotech company Illumina, the court found.
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iStock via Getty Images
Diagnostic errors are common. Here are 4 ways to prevent them.
A new, more holistic approach to testing is needed to avoid mistakes that can cause harm, said Marcus Schabacker, CEO of the patient safety group ECRI.
Updated Sept. 11, 2024 -
Courtesy of Abbott
Abbott debuts Lingo over-the-counter CGM in the US
Priced at $49 for one 14-day sensor, or $89 per month, Abbott’s offering is competitive with Dexcom’s Stelo sensor.
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Mario Tama via Getty Images
Judge orders J&J to pay Auris investors more than $1B for merger violations
J&J did not provide Auris Health with resources to achieve regulatory milestones after acquiring the robotics company in 2019, the judge found.
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Courtesy of Edwards Lifesciences
Edwards cuts more than 500 employees after critical care sale
An Edwards spokesperson said the layoffs, affecting 3% of its workforce, are a “one-time right-sizing” deemed necessary following the division’s sale to BD.
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Permission granted by Abbott Laboratories
Abbott partners with maker of ‘bionic pancreas’
Abbott will integrate its latest glucose sensor with Beta Bionics’ automated insulin delivery system.
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Retrieved from The Food and Drug Administration.
FDA cracks down on ozone cleaners for CPAP machines
The agency sent warning letters to four companies and reminded the public it has not authorized any devices for cleaning or disinfecting CPAPs.
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Courtesy of Insightec
Medtech venture investment recovery continues, but startup M&A remains limited: Pitchbook
Acquisitions of late-stage VC startups have been rare, a fact Pitchbook attributed to “ongoing price gaps between buyers and sellers.”
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SDI Productions via Getty Images
European heart group recommends renal denervation for some patients
The European Society of Cardiology said the treatment may be considered for certain patients with uncontrolled, drug-resistant high blood pressure but outlined lingering concerns.
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andresr via Getty Images
AI still the most exciting emerging technology for healthcare: survey
AI was the most compelling new technology for the fourth year in a row, with leaders also saying the technology had shown the most improvement, according to the Center for Connected Medicine.
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Courtesy of Grail
Illumina avoids fine for Grail purchase in European court victory
Illumina will avoid a penalty of 432 million euros after a court ruled the European Commission did not have jurisdiction to challenge the company’s Grail acquisition.
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Permission granted by Nasdaq
Embecta gets FDA nod for insulin patch pump
Embecta’s first patch pump features a larger insulin reservoir, based on feedback from people with Type 2 diabetes.
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Win McNamee/Getty Images via Getty Images
ARPA-H program to focus on AI degradation in medical tools
The agency will fund work to identify and auto-correct AI-enabled tools that are misaligned with their underlying training data.
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Permission granted by Medtronic
Medtronic’s chief medical officer of acute care and monitoring departs for new role
Sam Ajizian leaves Medtronic six months after the company reversed a plan to split off its patient monitoring business.
