Theranica Bioelectronics Ltd. has snagged an expanded clearance from the U.S. FDA for use of its smartphone-controlled Nerivio device to treat migraines in adolescents. The new indication, for acute treatment of episodic or chronic migraine in people 12 years and older, is supported by a study published last month in the journal Headache.

The portable hemodialysis market is heating up. For example, Quanta Dialysis Technologies Ltd. recently made a splash by receiving clearance from the U.S. FDA to market its portable hemodialysis system SC+. According to the Alcester, U.K.-based company, SC+ can deliver the higher dialysate flow rates typically used to provide conventional three-times-a-week prescriptions, while also offering the flexibility for more frequent, longer and gentler treatments tailored to patients’ needs.

Boston Scientific Corp. has received a thumbs up from the U.S. FDA for its fourth-generation Vercise Genus deep brain stimulation (DBS) system. The neuromodulation device, which comes in both rechargeable and nonrechargeable versions, is intended to treat the symptoms of Parkinson’s disease. Vercise Genus is indicated for use in the bilateral stimulation of subthalamic nucleus as an adjunctive therapy in alleviating some of the symptoms of moderate to advanced lepodova-responsive Parkinson’s disease that are not adequately controlled by medication. It also has indications for bilateral stimulation of the globus pallidus.

PERTH, Australia – Following consultation with medical device stakeholders in 2019 and 2020, the Therapeutic Goods (Medical Devices) Regulations 2002 were amended to clarify some existing requirements and to introduce new requirements for software-based medical devices. The new rules that go into effect on Feb. 25, 2021, clarify the boundary of regulated software products, introduce new classification rules, and provide updates to the essential principles for software-based medical devices.

The implementation date for the European Union’s In Vitro Diagnostic Regulation (IVDR) is a mere 16 months away, although there is widespread interest in a delayed implementation date. Nonetheless, Warren Jameson, principal regulatory consultant for North American Science Associates (NAMSA) of Toledo, Ohio, urged test makers to conduct a gap analysis of the conformity of their currently marketed tests to the new regulations because a large percentage of the underlying dossiers would not pass muster under the terms of the new regulatory regime.

HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has greenlighted Seoul-based Vuno Inc.’s artificial intelligence (AI)-based solution Vuno Med Deepbrain for use as a class III medical device, which is a classification for moderate risk level devices. The MFDS approval was given on Dec. 29, 2021, a Vuno spokesperson told BioWorld, but the company only disclosed the approval earlier in the week. The reasons for the delayed announcement were not disclosed.