FDA

IPS has an apoptosis for destruction, and that’s cool

By GREGORY ZELLER // Chilling news from Intelligent Product Solutions, which has reshaped a body re-shaper that slices with hot lasers and soothes with cooled air. That’s the general gist of the eon FR, a “non-contact aesthetic device” that cuts away abdominal fat cells with laser energy while cooling the patient’s target areas with blasts of cold air. The product, which earned FDA clearance in June, comes from Dominion Aesthetic Technologies, a circa-2016, Florida-based medical-device…


Debrief: Innovations past and future, with Marc Alessi

  Arguably the hardest-working man in Long Island innovation, former New York State Assemblyman Marc Alessi enjoys a singular socioeconomic viewpoint. The entrepreneur and champion of 5G connectivity has had a productive year as both executive director of the Business Incubator Association of New York State and executive director of Shoreham’s Tesla Science Center at Wardenclyffe, all while leading his 2014 advanced-scanning startup SynchroPET to the edge of commercialization and chairing Campolo, Middleton & McCormick’s…


BioPosture: Septuagenarian entrepreneurs bounce back

By GREGORY ZELLER // From the Going in Style File comes Sleep BioLogics Inc., a startup from two 70-something entrepreneurs who wouldn’t take retirement lying down. Actually, Sleep BioLogics is a 2018 reinvention of a 2016 startup, RV Winkle LLC, which itself was a “bed in a box” enterprise several years in the making. It all started because Irwin Pearl and Tom Williams, who’d both enjoyed long and successful business careers, weren’t ready to call…


Alessi: LI must work together on a 5G future

By MARC ALESSI // It’s no secret that Long Island has problems with cellphone service. More than 200 cellphone “dead zones” were identified in late 2016, as well as poor-quality network speed, reliability and performance. U.S. Senator Chuck Schumer (D-NY) has even urged carriers to improve coverage on the Island. As a longtime resident of the North Shore, I have witnessed firsthand what it means to not have reliable wireless connectivity with our mobile-enabled electronics….


For food manufacturers, MTRC/LIFC spells “growth”

By GREGORY ZELLER // Some fairly thick alphabet soup will create a tasty economic-development stew for regional food manufacturers. The Manufacturing & Technology Resource Consortium is partnering with the Port Washington-based Long Island Food Council on a multifaceted effort to bring expert consulting services to food manufacturers in Nassau and Suffolk. The MTRC/LIFC partnership will be a resource for clients of the MTRC, which is located on the Stony Brook University campus and serves as…


Concussion-focused Scythian sets market debut

By GREGORY ZELLER // Scythian Biosciences Corp. is going public. The New York City/Toronto-based biotech, led by Great Neck investment banker Jonathan Gilbert on its quest to develop the world’s first pharmaceutical treatment for concussions, will begin trading Aug. 8 on the TSX Venture Exchange, one of Canada’s major stock markets. Projected to open at $8 (Canadian) per share, Scythian Biosciences (ticker symbol “SCYB”) will float upwards of 2.5 million shares – about half of…


FDA has a date for stem cells hearing

The Food and Drug Administration has rescheduled a critical public hearing on potential regulations for the burgeoning stem cell industry. “Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products” will now be held Sept.12 and 13 inside the Masur Auditorium on the National Institutes of Health’s Bethesda, Md. campus. Originally scheduled for April 13, the hearing was postponed due to what the FDA called “considerable…


FDA pushes off stem cell hearing

The Food and Drug Administration has indefinitely postponed a public hearing on stem cell regulation due to what it called “considerable interest.” “Due to this interest, and to give stakeholders additional time to provide comments to the agency, FDA intends to extend the comment period for the draft guidance documents,” the administration said on its website. The April 13 hearing was shaping up as a public showdown between opponents and supporters of stem cell-based research…