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BioWorld - Tuesday, May 12, 2026
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Medical technology
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Regulatory actions for August 23, 2024

Aug. 23, 2024
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aisap, Qure.ai, Neurocare.
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Thumbs down

Implant still can’t; Vivani bonny vs. Intarcia with exenatide?

Aug. 23, 2024
By Randy Osborne
The long struggle by Boston-based I2o Therapeutics Inc.’s business unit Intarcia Therapeutics to get long-lasting exenatide for diabetes onto the market ended with a final thumbs-down from the U.S. FDA because of safety concerns. At issue was ITCA-650, a twice-yearly implantable exenatide-device combo meant to improve glycemic control in adults with type 2 diabetes.
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Gavel and vials

FTC noncompete ban struck down by district court

Aug. 22, 2024
By Lee Landenberger
The U.S. Federal Trade Commission’s broad rule banning noncompete employment clauses was struck down by the U.S. District Court for the Northern District of Texas. In a final judgment from Judge Ada Brown, the court set aside the noncompete rule, saying it won’t be enforced or take effect as planned on Sept. 4.
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Medtronic Percept RC

FDA approves Medtronic Asleep DBS surgery, expanded MRI labeling

Aug. 22, 2024
By Shani Alexander
The U.S. FDA recently granted Medtronic plc approval for its deep brain stimulation (DBS) system to be used to treat Parkinson’s disease or essential tremor while a patient is asleep, under general anesthesia. The approval gives patients another option for DBS therapy which can transform their quality of life, Amaza Reitmeier, vice president and general manager for Medtronic brain modulation, told BioWorld in an interview.
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Stock merger illustration

Stryker strikes again with acquisition of Vertos

Aug. 22, 2024
By Annette Boyle
Stryker Corp. continued its aggressive M&A program this year with the planned acquisition of Vertos Medical Inc. Vertos offers a minimally invasive lumbar decompression (Mild) solution for chronic lower back pain caused by lumbar spinal stenosis. The announcement brings Stryker to six deals so far this year: Société d'Etudes, de Recherches et de Fabrication (SERF) SAS, Mfphd LLC, Artelon Inc., Molli Surgical Inc., Care.ai Inc. and now Vertos. Financial terms were not disclosed for any of the transactions.
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Regulatory icons

FDA sees change in sterilization site as inappropriate for PCCPs

Aug. 22, 2024
By Mark McCarty
The U.S. FDA’s draft guidance for predetermined change control protocols for all device types fills in a gap left by previous draft guidance, but there is one potential stopping point for class III devices.
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Harrell ALS BCI

Brain-computer interface restores ALS patient's voice

Aug. 22, 2024
By Holland Johnson
A new brain-computer interface (BCI) developed at UC Davis Health is able to translate brain signals into speech with up to 97% accuracy – the most accurate system of its kind.
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Financings for August 22, 2024

Aug. 22, 2024
Med-tech firms raising money in public or private financings, including: Beme Health.
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Appointments and advancements for August 22, 2024

Aug. 22, 2024
New hires and promotions in the med-tech industry, including: Ingenza, Cleerly, Dotmatics.
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In the clinic for August 22, 2024

Aug. 22, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Angle, University of Eastern Finland.
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