Ensuring medical devices are shielded from cybersecurity threats is, in the words of the U.S. Food and Drug Administration, a "shared responsibility" among all stakeholders. Medical technology companies, hospitals, physicians, IT professionals, providers, regulators and patients all need to work together so that the safety and integrity of interconnected medical devices – everything from pacemakers and ICDs to monitors and infusion pumps – is not compromised due to cyber threats.
NEWTOWN, PA., April 11, 2018 - Helius Medical Technologies, Inc. (“Helius” or the “Company”) today announced the pricing of an underwritten public offering of 2,141,900 shares of its Class A common stock and warrants to purchase 2,141,900 shares of its Class A common stock at a public offering price of US$7.47 per share and accompanying warrant, before underwriting discounts and commissions. The net proceeds to the Company from this offering, after deducting the underwriting discounts,...
California-based Myoscience, Inc. announced today that it received 510k clearance from the US FDA for Smart Tip with Nerve Stim, the latest innovative tip for Myoscience’s iovera° platform technology.
With the FDA clearance for Smart Tip with Nerve Stim, physicians will be able to stimulate a nerve in advance of delivering iovera° cold therapy to the treatment area, reducing patient treatment times. Additionally, the use of Smart Tip with Nerve Stim enables physicians using iovera° to access...
It sometimes strikes without warning. People of any age, race, ethnicity and gender are at risk. In fact, it is the leading killer of both men and women in America. It is heart disease, and each year it claims the lives of over 600,000 Americans, accounting for one-quarter of all deaths in the United States.
Boston Scientific commends the efforts of key champions in the U.S. House and Senate for their successful efforts to suspend the medical device tax, allowing the device industry to reinvest in work to benefit patients.
LINCOLNSHIRE, ILL. – Nov. 8, 2017 – Sysmex America announced today that its Sysmex XW-100 received clearance from the U.S. Food and Drug Administration (FDA)—making it the first Clinical Laboratory Improvement Amendments (CLIA)-waived, complete blood count (CBC) system. Once prepared for each day’s use, the XW-100 will allow health care professionals to provide patients with blood test results in as few as three minutes.