Spotlight On... FDA clears imaging system to detect vision disorders in newborns; Insulin pump maker Valeritas withdraws IPO; Avita grabs splashy China distribution deal; and more...

Fremont, CA's Visunex Medical Systems announced FDA clearance of its PanoCam Pro Wide-field Imaging System for the detection of vision disorders in newborns. Visunex says it is the first wireless integrated hardware and software platform for capturing images of the back of newborns' eyes. Images can be stored in the cloud or at an associated review station. The test is supposed to be performed prior to hospital discharge. "We are launching the PanoCam Pro, which is a key product to help Ophthalmologists and Maternal Clinicians identify vision disorders to help preserve vision in the NICU, OR, Birthing Centers and Clinical Offices," said CEO Dr. Wei Su in a release. "Our PanoCam Pro and PanoCam Review Software will help clinicians identify vision disorders that may be reversed to preserve healthy vision." Release

@FierceMedDev: FDA loss in Vascular Solution off-label promotion case foreshadowed Amarin settlement, Artlce | Follow @FierceMedDev

@VarunSaxena2: Hmmm... all the media bumpkins can say Rubio won again. This is all you need to know. | Follow @VarunSaxena2

@EmilyWFierce: Apple plots smartphone-based medical device application for Apple Watch. Article | Follow @EmilyWFierce

> Disposable insulin pump maker Valeritas has withdrawn its proposed $75 million IPO. More

> Australian micro-cap Avita Medical ($AVH) will be distributed by the largest healthcare group in China, Sinopharm, under a new deal. Its devices deliver a cellular suspension to trigger healing in burns and chronic wounds. Its ReCell device for burns and plastic reconstructive procedures is approved in China, Australia and Europe; it is in a pivotal U.S. trial aimed at FDA approval. More

> Low-energy x-ray systems maker Sensus Healthcare, which focuses on treating non-melanoma skin cancer and keloids, set terms for its IPO to raise as much as $24.4 million. More

Biotech News

@FierceBiotech: Corvus shoots for $80M in an IPO to support its immuno-oncology pipeline. News | Follow @FierceBiotech

@JohnCFierce: Interesting to think that pointing out what Trump got wrong could become a full-time job for the next 4 years. More | Follow @JohnCFierce

> GlaxoSmithKline dumps Five Prime's cancer drug in the midst of Phase I. Story

Pharma News

@FiercePharma: BeiGene approved to start China leg of global BTK inhibitor trial. Story | Follow @FiercePharma

@EricPFierce: Vertex, committed to continuous manufacturing, has Hovione build plant to complement the one it already has. Story | Follow @EricPFierce

@CarlyHFierce: Perrigo execs collect $2.75M in bonuses for fending off Mylan takeover. More | Follow @CarlyHFierce

> EMA puts Gilead's Zydelig under the lens after deaths crop up in trials. Article