The Centers for Medicare and Medicaid Services (CMS) has started an analysis for a national coverage determination (NCD) for its coverage of leadless cardiac pacemakers. This decision is likely to prove key not only for its patients, but for coverage of the device category by U.S. private insurers as well. This opens a 30-day comment period to the agency. It notes that leadless pacemakers eliminate the need for a subcutaneous pocket to insert the pacemaker, as well as the insertion of pacing leads--both of which are sources of potential complications--while providing similar benefits. Medtronic ($MDT) nabbed the first FDA approval for a leadless pacemaker in early April. More
> The FDA has cleared the first technology for oral tissue and bone regeneration via a laser-assisted procedure from Millennium Dental Technologies. It's cleared specifically for periodontal regeneration. More
> Oncology device company Pulse Biosciences ($PLSE) has priced a $20 million IPO, selling 5 million shares at $4 each. That gives it a market cap of $51 million. It uses pulsed electric fields to treat solid tumors. More
> Startup Xeltis has reported positive pediatric feasibility data from its trial for a bioabsorbable heart valve that enabled tissue restoration. More