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BioWorld - Thursday, December 25, 2025
Home » Topics » U.S., BioWorld MedTech

U.S., BioWorld MedTech
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US flag, gavel, book

Spinefrontiers CEO sentenced to one year of supervised release

Aug. 11, 2025
By Mark McCarty
Kingsley Chin, the CEO of Spinefrontier Inc., has been sentenced to a year of supervised release for his role in the payment of less than $5,000 in consulting fees to a surgeon who provided no consulting services.
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Dollar sign dropper and test tube

Trump EO to change the landscape of US grants, awards

Aug. 11, 2025
By Mari Serebrov
No Comments
Billing it as a necessary reform to protect tax dollars from frivolous government spending, redundancy and waste, U.S. President Donald Trump issued a new executive order (EO) requiring his political appointees to sign off on grants and awards from agencies such as the NIH and to monitor those awards over time to ensure they’re being used properly.
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Businessman and IPO virtual screen

Heartflow raises $317M, pops 66% at market open

Aug. 8, 2025
By Annette Boyle
Heartflow Inc. upped the price of shares in its IPO for a second time to $19 on Aug. 7 before opening on the Nasdaq as “HTFL” at $28 and climbing to $31.50 in early trading. The IPO raked in $316.7 million for the 16.67 million shares sold, giving the cardiology company a valuation of $2.27 billion.
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Boston Scientific - Watchman FLX

FDA says Watchman access alert remedied by review of IFU

Aug. 8, 2025
By Mark McCarty
The U.S. FDA posted an Aug. 6 early alert regarding the use of the Watchman left atrial appendage device by Boston Scientific Corp., citing instances in which the device’s delivery system is associated with events of embolism.
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Instylla Inc Embrace

Instylla wins FDA PMA for Embrace hydrogel embolic system

Aug. 8, 2025
By Holland Johnson
Just two days after reporting the appointment of a new CEO, Instylla Inc. said it received a premarket approval from the U.S. FDA for its flagship product Embrace hydrogel embolic system. Embrace HES has been approved for the embolization of hypervascular tumors in peripheral arteries.
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Green, blue, gray dollar signs

Histosonics sells majority stake for $2.25B

Aug. 7, 2025
By Annette Boyle
A management-led syndicate of prominent investors acquired a majority stake in Histosonics Inc. that values the company at approximately $2.25 billion. The funding will support expansion of the Edison Histotripsy system and therapy platform into new clinical indications and markets. Edison uses non-invasive focused ultrasound energy to destroy tumors.
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Gavel and FTC logo

US FTC moves to thwart Edwards’ acquisition of Jenavalve

Aug. 7, 2025
By Mark McCarty
The U.S. Federal Trade Commission (FTC) reported Aug. 6 that it will try to block Edwards Lifesciences Corp.’s proposed acquisition of Jenavalve because Edwards’ acquisition of both Jenavalve Technology Inc. and JC Medical would eliminate competition in the TAVR space for aortic regurgitation.
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Bitcoin surrounded by coins and financial charts, symbolizing cryptocurrency and digital investment

Biopharmas launch new crypto financing strategies

Aug. 7, 2025
By Karen Carey
No Comments
With half-year industry financings down 59% from last year, and a U.S. administration supportive of cryptocurrencies, biopharma companies are building treasuries of digital assets to secure future R&D efforts and operational runways. Companies such as Artelo Biosciences Inc., MEI Pharma Inc., Windtree Therapeutics Inc. and 180 Life Sciences Corp. and have entered crypto deals in recent weeks, with the latter noting the potential to “unlock value outside traditional biotech milestones.”
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Red arrow pointing downward on a stock market ticker

Bio-Techne takes a hit on Exodx sale to Mdxhealth

Aug. 6, 2025
By Annette Boyle
Bio-Techne Corp. plans to sell its Exosome Diagnostics Inc. business to Mdxhealth SA for $15 million plus royalty payments, a steep cut from the $250 million the company paid to acquire Exodx in 2018. Mdxhealth estimates the unit will generate $20 million in revenue in 2026.
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US flag and HHS logo

HHS appoints acting general counsel as FDA chief counsel

Aug. 6, 2025
By Mark McCarty
The U.S. Department of Health and Human Services has tapped Sean Keveney for the job of FDA chief counsel, but the recent history of the position muddies the waters when it comes to HHS oversight of FDA legal affairs.
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