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BioWorld - Friday, January 16, 2026
Home » Topics » U.S., BioWorld MedTech

U.S., BioWorld MedTech
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US flag and HHS logo

Pallone, DeGette push back on FDA, other HHS dismissals

March 3, 2025
By Mark McCarty
The rash of firings at agencies of the Department of Health and Human Services has provoked a Feb. 28 letter from Reps. Dianna DeGette (D-Colo.) and Frank Pallone (D-N.J.), blasting the dismissals and insinuating that the dismissals were politically motivated.
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Regulatory icons

US PTO peels back 2022 memo on discretionary denials of IPRs

March 3, 2025
By Mark McCarty
The U.S. Patent and Trademark Office has reversed a 2022 agency memorandum on discretionary denials of patent procedures, such as inter partes reviews.
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Brain and neural networks

Precision Neuroscience initiates brain computer interface study

March 3, 2025
By Shani Alexander
Precision Neuroscience Inc. recently partnered with Beth Israel Deaconess Medical Center to test its brain computer interface, the Layer 7 Cortical Interface, during craniotomy procedures.
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Google Pixel Watch 3 Loss-of-pulse

FDA clears loss-of-pulse detection on Google Pixel Watch 3

Feb. 28, 2025
By Annette Boyle
The Apple Watch may be able to alert wearers to heart palpitations, but Google LLC’s Pixel Watch 3 can now detect when a user’s heart stops – and call emergency services. The pulse detection featured received clearance from the U.S. FDA on Feb. 26 and Google plans to make it available on its Pixel Watch 3 starting in March. Pulse detection is already available for watches sold in the U.K. and EU.
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Tug-of-war illustration

Novelty of PCCP filings a source of drag for FDA, industry

Feb. 28, 2025
By Mark McCarty
Nick Decker, directory of global regulatory policy for Roch Holding AG’s Roche Diagnostics division, said the FDA is moving carefully into the PCCP space, and industry, too, is taking a measured approach in adopting the PCCP concept.
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Gray and green glass dollar symbols with arrow pointing up

Teleflex buying Biotronik’s vascular intervention unit for $791M

Feb. 27, 2025
By Annette Boyle
In a flurry of news releases on Feb. 27, Teleflex Inc. reported plans to buy the vascular intervention business of Biotronik SE & Co. for €760 million (US$791 million), said it intended to split into two separate public companies, floated a $300 million accelerated share repurchase program and reported the impending retirement of Chief Financial Officer Thomas Powell. The news sent the company stock down more than 20%.
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Singapore

Basel Medical prices $8.8M IPO

Feb. 27, 2025
By Marian (YoonJee) Chu
Basel Medical Group Ltd. is the first Singapore-based med-tech to price an IPO on the Nasdaq this year, aggregating gross proceeds of $8.82 million on its debut. The funds will be used to power future M&As and business expansion plans in Singapore and Southeast Asia, the company said.
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Woman holding display of business, regulatory icons

Little interest shown in premarket use of MDSAP audits

Feb. 27, 2025
By Mark McCarty
A number of regulatory agencies have signed on to the Medical Device Single Audit Program (MDSAP) for postmarket uses, but the U.S, FDA cannot use these audits for premarket purposes.
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Tandem

Tandem wins FDA clearance for automated insulin delivery system

Feb. 27, 2025
By Holland Johnson
Tandem Diabetes Care Inc. reported that its next-generation automated insulin delivery algorithm, Control-IQ+ technology (Control-IQ+), is cleared by the U.S. FDA for use by people with type 2 diabetes (T2D) ages 18 and older.
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Illustration of tumor on kidney

FDA accepts Telix BLA for kidney cancer imaging agent

Feb. 26, 2025
By Tamra Sami
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
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