Pear Therapeutics Inc. has seen its efforts in the prescription digital therapeutics (PDT) space come to fruition with two new deals reported this week. The Hartford Financial Services Group Inc. now covers two of the company's therapeutics – Reset, for substance use disorder, and Reset-O, for opioid use disorder – for its employees and their beneficiaries. Preferredone will also cover the two PDTs for all its members.
The U.S. FDA has posted another draft version of the intended use rule, this time with a fix for the so-called knowledge problem. This latest draft would eliminate mere knowledge of off-label use as a trigger for amendments to the product label, a provision the agency said in a Sept. 22 statement will “provide greater certainty and predictability for regulated parties.”
Corza Health Inc. has agreed to pay Takeda Pharmaceutical Co. Ltd. €350 million (US$409.8 million) in cash to acquire the Japanese drugmaker’s Tachosil fibrin sealant patch. The deal, which is expected to close by March 31, 2021, pending regulatory approvals, gives Corza Health a solid footing in the advanced wound care and closure market.
According to the Swiss association for medical technology companies, Swiss Medtech, introducing the new European regulations for medical devices (MDR) and in vitro diagnostics (IVDR) is going to have serious consequences for the sector in Switzerland. This Swiss trade association has just published its biannual survey as part of the 2020 sector study on the Swiss medical technology industry (SMTI).
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Ambulatory Surgical Center Association, Dyansys, Neurosurgical Care.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Life Spine, Medhub, Medtronic, Nanovibronix, Radlogics, Rti Surgical.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Clinical Genomics, Owlstone Medical, Precision Diabetes.
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