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Cardiovascular Catch-Up: Philips New AI Finds AF Needle In ECG Haystack; LimFlow Moves Closer To US Approval

 
• By Reed Miller

Medtech Insight’s Cardiovascular Catch-Up highlights recent news and insights from cardiovascular device companies – big and small. Part two of this month's installment includes updates from lesser-known companies that you might have missed, including Cardiologs, Rhythm Management, LimFlow and ShockWave.

• Source: Alamy

Results of a new clinical study showed Philips/Cardiologs’ deep learning artificial intelligence algorithm can predict the short-term risk of atrial fibrillation based on 24-hour Holter monitor recordings, even when there are no visible signs of impending atrial fibrillation in the electrocardiogram (ECG) recordings.

Jagmeet Singh of Massachusetts General Hospital in Boston presented the results of the study as a poster at the American...

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Injuries And Deaths Linked To Boston Scientific Cardiac Devices. Company Responds

 
• By Brian Bossetta

The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.

Ultromics Wins $55M, The Key To Success: Diagnosing Diseases With Available Treatment

 
• By Natasha Barrow

Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.

Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 
• By Natasha Barrow

Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.

Injuries And Deaths Linked To Baxter Infusion Pump

 
• By Brian Bossetta

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

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FDA Ends Effort To Regulate LDTs By Rescinding Final Rule

 
• By Brian Bossetta

Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.

Exact Sciences Reveals Thinking On CRC Liquid Biopsy After Freenome Deal

 
• By Natasha Barrow

Exact Sciences has entered into an exclusive licensing agreement with Freenome, stipulating clinical benchmarks and a first-line rating in the USPSTF guidelines. Medtech Insight interviewed screening CMO Paul Limburg about CRC screening and Exact’s strategy on liquid biopsy.

Fresh Off $100M IPO, Carlsmed Plans For Growth, 2026 Launch Of Customized Cervical Fusion Implant

 
• By Marion Webb

Fresh off an IPO, spinal implant maker Carlsmed is preparing to launch a new cervical fusion application for its aprevo tech. Medtech Insight has two perspectives on these recent moves: CEO Mike Cordonnier and the doctor who performed the first spinal fusion using the technology.