These medtech companies raised the most VC last year

Perhaps there’s a ray of hope that venture capital funding is recovering a bit for the medical device industry. VC firms invested more than $2.8 billion in 2017, an increase of more than $647 million from 2016, according to the MoneyTree Report from PricewaterhouseCoopers (PwC) and CB Insights. There were a total 229 deals involving

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Medtech stories we missed this week: Jan. 19, 2018

From Privi Medical’s FDA clearance to OrthoXel getting FDA clearance and CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Privi Medical wins FDA nod for hemorrhoid device Privi Medical has received FDA clearance for its Instalief Hemorrhoids Treatment device, according to a Jan. 18 news

Phillips-Medisize’s increased business to benefit Molex plant in Arkansas

Phillips-Medisize today announced a doubling of production for an undisclosed fast-growing medical customer with a take-home diagnostic kit for cancer detection – with benefits for the plant that Phillips-Medisize’s parent Molex runs in Little Rock, Ark. Phillips-Medisize, which is based in Hudson, Wis., did not disclose the identity of the customer, which it described as a leader

Cardiovascular Systems inks partnerships with OrbusNeich, Integer

Cardiovascular Systems (Nasdaq: CSII) announced today that it is expanding its product portfolio through new partnerships with OrbusNeich and Integer. The OrbusNeich partnership makes St. Paul, Minn.–based CSI the exclusive U.S. distributor of Hong Kong–based OrbusNeich‘s balloon products. The deal with Frisco, Texas–based Integer (NYSE: ITGR) involves Integer producing CSI-branded Zilient guidewires. Cardiovascular Systems CEO

FDA to expedite release of recall information

Douglas Stearn, FDA When FDA identifies that a product it regulates violates the law, it protects the public by working with the manufacturer and distributors to facilitate the product’s recall (i.e., removal from the marketplace or product correction). Among other actions, FDA assures that the public is warned when products present the most significant public

IRS won’t enforce penalties on medical device tax

The U.S. Internal Revenue Service yesterday said it won’t enforce penalties on companies making late payments on the medical device tax for the first three months of this year. The 2.3% excise tax on U.S. medical device revenues was in effect for two years before a two-year moratorium went into effect for 2016 and 2017. It went […]

Is tax reform good or bad for medical device companies?

Medical device companies and others in the healthcare sector stand to benefit from the tax reform Congress passed at the end of 2017, but the picture isn’t entirely rosy, according to a new report from S&P Global Ratings. In many ways, the report offers a corrective to the bullish statements coming from corporate CEOs such

FDA releases top 3 medical device regulation goals

FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paper that FDA’s CDRH released today. The agency said the priorities further its overall goal of providing Americans with more timely access to the latest high-quality, safe and effective medical devices.

FDA needs to improve medical device regulation, GAO says

FDA is lacking performance metrics when it comes to tracking whether its medical device regulators are following a “least burdensome” approach toward asking applicants for additional information, according to a new report from the U.S. Government Accountability Office. The GAO says in the report highlights: “Until such measures are developed and used, FDA will not

Secant Group officials think they’ve cracked vascular regeneration: Here’s how

Secant Group today announced what it described as game-changing technology to advance vascular regeneration, solving problems that surgeons presently have when it comes to vascular harvesting and the non-resorbable synthetic graft compliance mismatching. The technology, which Secant (Telford, Pa.) developed in partnership with its sister company SanaVita Medical, involves a synthetic small bore vessel with a hollow

Northwire expands biocompatibility compliance

Northwire (Osceola, Wis.) announced that it has finished additional testing to certify its BioCompatic material line to be in accordance with ISO 10993-10 irritation and skin sensitization requirements. The company’s BioCompatic material is designed to create optimized, safe and dependable medical cables while meeting biocompatibility standards under USP Class VI and compliance to ISO 10993-5 cytotoxicity.

Abbott, Nevro tout spinal cord stimulation tech

Abbott (NYSE:ABT) and Nevro (NYSE:NVRO) touted their spinal cord stimulation technologies at the annual North American Neurological Society meeting in Las Vegas. Two-year data from Abbott’s 42-patient Sunburst study revealed that a majority of patients chose its BurstDR therapy when given the choice during the long-term follow-up period and that stimulation from BurstDR provided pain relief […]

Light-based medical products: What you need to know

Photonics technologies are everywhere but need a deft touch to integrate into light-based medical products. Scott Wohlstein, The Photonics Group Much like electronics is the study of the electron, photonics is the study of the photon and includes its generation/emission, transmission, detection and analysis. Incandescent/fluorescent light sources, UV lamps, lasers, LEDs, lenses, fiber optics, detectors

How laser marking could solve the medical device industry’s UDI challenges

Here are five ways that laser marking could provide advantages to medical device companies when it comes to meeting permanent marking requirements under FDA’s Unique Device Identification program. Ashir Thakore, SABIC As the U.S. Food and Drug Administration (FDA) implements its phased Unique Device Identification (UDI) program across medical device classes, OEMs are considering methods

FDA warns BD over blood collection tubes used in Magellan’s lead testing kit

The FDA issued a warning letter to Becton Dickinson & Co. (NYSE:BDX) today, citing a number of violations of federal law that it identified in an inspection of the company’s New Jersey facility. The inspection, which was done as part of the agency’s ongoing investigation into the cause of inaccurate blood lead tests linked to Magellen […]