The bankruptcy of genetic testing service 23andme Holding Corp. prompted a reaction from many quarters, but a June 11 Senate hearing highlighted an interest in federal privacy legislation that would be directed toward genetic privacy as well as comprehensive and preemptive federal privacy legislation.
The U.K.’s National Health Service reported June 10 that patients in the U.K. will be the first in Europe to enjoy the benefits of the Edison ultrasound histotripsy for ablation of liver cancer tumors as part of an effort to bring products to market more quickly to deal with unmet needs.
London-based Livanova plc. has petitioned the U.S. CMS to cover vagus nerve stimulation device for treatment-resistant depression without the need for a clinical trial — a change that would eliminate the costly and cumbersome coverage with evidence development mechanism.
Australia’s Therapeutic Goods Administration initiated court proceedings against Philips Electronics Australia Ltd. over sound abatement foam used in CPAP machines marketed under the Respironics brand.
The U.S. FDA’s Center for Devices and Radiological Health is recovering from a guidance drought that spanned several months in the first part of calendar year 2025, starting with a guidance on the Q-sub process.
U.S. Medicare coverage of telehealth and telemedicine sometimes seems to lag inappropriately, but fears of fraud were borne out in a conviction obtained recently by the Department of Justice.
The U.S. Federal Trade Commission said it sent letters to 37 contact lens prescribers reminding them a failure to automatically provide patients with a prescription can result in fines of more than $53,000 per violation.
The U.K. National Institute for Health and Care Excellence reported it will streamline its health technology assessment, but the bigger news might be that the agency will no longer require new technologies prove to be cost saving to win an endorsement from the agency.
