Two of the three largest venture rounds in U.S. life science startups last quarter went to medical device companies. That's a bit of an unusual state of affairs for med tech--which sometimes has the reputation of getting investment in dribs and drabs to back tech that's none too innovative.
MRI contrast agents are often metallic--and have known toxicity issues with some shown to remain in the body longer-term as deposits in the brain.
Google parent company Alphabet has been slow to reveal financial details on its newer businesses. But now Google co-founder and Alphabet executive Sergey Brin is starting to offer some insights. He told company employees at a recent meeting that Verily, its med tech-focused business, is already profitable on a cash basis, tech pub Re/code reported.
UPDATED: Boston Scientific faces grand jury probe over allegedly counterfeit material for vaginal mesh
Boston Scientific is facing more pushback in its legal saga over vaginal mesh implants. Federal prosecutors are convening a grand jury to consider evidence that the company used defective counterfeit raw materials from China for its devices.
Reflexion Medical has raised $46 million to develop the first biology-guided radiotherapy system that offers targeted cancer treatment. Last fall, the Hayward, CA-based startup said it had created a prototype device that was ready to go into the clinic. This Series B infusion is earmarked for expanding the company's engineering, regulatory and commercial groups.
The FDA slapped Quest Diagnostic's Focus Diagnostics unit with a Class I recall over some of its lab examination kits after the tools produced inaccurate test results.
Regulators have had a lot of strong words for Theranos CEO Elizabeth Holmes lately, and now, they're sending a new message to the leader of the embattled testing company: Get out.
The body's response to foreign material--forming blood clots and becoming inflamed--can prevent blood-contacting implants like stents and heart valves from working properly. While the only recourse is to replace the device, Harvard scientists have developed a new biochemical method to coat these devices to preserve their function.
Dx Digest: Epigenomics wins FDA approval for colorectal cancer test; NanoString and HalioDx team for immuno-oncology Dx
Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the diagnostics industry. Testing heavyweight Siemens got an FDA nod for its Graves' disease (GD) test. Epigenomics also got a regulatory blessing for its colorectal cancer screening tool. Last but certainly not least, NanoString Technologies and HalioDx teamed up to develop immuno-oncology gene expression tests.
Medtronic has released the latest study results from its MiniMed insulin pumps.
Flagship Ventures startup aims for FDA, EU approval of painless blood collection device by this summer
Seventh Sense Biosystems has started a pivotal trial of its novel microneedle painless blood collection device. It draws blood from the capillaries, without having to puncture a vein or fingertip. The goal is to offer a device that will easily facilitate point-of-care testing--obviating the need for standard blood draws in a dedicated diagnostics laboratory.
Cellnovo Group is already part of a major NIH trial for an artificial pancreas that incorporates its connected insulin pump-blood glucose monitor. Now, it's joining a European Commission-sponsored R&D project to develop new technology aimed at Type 1 diabetics.
Biotronik scored FDA approval for its insertable cardiac remote monitor, giving the company a boost in a crowded market. Regulators signed off on Biotronik's BioMonitor 2, a subcutaneous device that helps doctors flag and diagnose heart conditions including atrial fibrillation, ventricular tachycardia and fibrillation, and strokes.
Medtronic has taken some responsibility for mishandling data from a retrospective chart review of its bone graft, Infuse, after a recent report said that the company allegedly buried side effect reports linked to the product. But Medtronic's response did not appease one lawmaker, who is calling on the company and regulators for more answers.
Orthopedics implant and spine player Stryker has acquired Florida-based startup SafeWire in order to add to its minimally invasive spinal surgery products. Stryker has been on an M&A tear of late--this deal follows the closure of three acquisitions earlier this month.
Google will award a series of grants of roughly $500,000 to $1.5 million apiece to the 30 nonprofit winners of its Impact Challenge for innovative technology to address the needs of the disabled.
Highly regarded medical device incubator, The Foundry, has secured a Series B financing for one of its newest and more mysterious efforts--Fire1. The company's sole disclosure on its efforts thus far are that it is working on novel remote monitoring devices.
CeQur is gearing up to launch its adhesive wearable insulin device that automatically delivers up to three days of insulin to patients with Type 2 diabetes. It's doubling its Marlborough, MA-based facility to add a manufacturing line, clean room and labs. That follows a whopping $100 million Series C that the company disclosed last fall.
Digital health startup Livongo Health reeled in $44.5 million in Series C financing to support development of its cloud-based diabetes management technology.
iStar Medical raised a €10 million ($11.4 million) Series B round to fund a study to support a CE mark for its latest product. Its MiniJect is an injected implant that is designed to reduce intraocular pressure in glaucoma patients by improving aqueous humor outflow from the anterior chamber to the suprachoroidal space.