KemPharm (NSDQ:KMPH) said yesterday it inked a collaborative licensing deal with KVK Tech to obtain U.S. commercial rights to the company’s FDA-approved Apadaz drug. Through the agreement, KemPharm is eligible to receive approximately $3.4 million in pre-launch payments and core cost reimbursement, including a $2 million milestone payment “related to the initial formulary adoption of Apadaz. […]
Philips-Medisize launches third-gen Connected Health Platform
Phillips-Medisize said today it completed the roll-out of its third-gen Connected Health Platform, a cloud-based data system for pharmaceutical and drug delivery device developers. The newly launched system includes information sharing and analytics capabilities as well as cybersecurity precautions and streamlined regulatory documentation, the Hudson, Wisc.-based company said. The third-gen Connected Health Platform includes an […]
Medtronic wins FDA nod for SynchroMedII myPTM drug therapy manager
Medtronic (NYSE:MDT) said today that the FDA approved its new SynchroMedII myPTM personal therapy manager intended for use in treating patients with chronic pain. The newly cleared device works with the company’s SynchroMedII intrathecal drug delivery system and is designed to handle delivering on-demand boluses within therapeutic limits set by physicians, the Fridley, Minn.-based company said. […]
Medtech issues again take center stage in Minn. Congressional races
The medical device industry is yet again positioned to play a major role in Minnesota congressional races. Incumbent Rep. Erik Paulsen (R-Minn.), who has been a longtime supporter of the medtech industry and led numerous attempts to repeal the medical device tax, is facing a tough re-election campaign. Paulsen is facing off against 48-year-old liquor […]
Report: Next-gen Amazon Alexa could detect illness, provide medicine suggestions
Future generations of Amazon‘s (NSDQ:AMZN) Alexa virtual assistant may be able to determine when its users are ill and provide medication recommendations, according to a new report from The Telegraph. The online retail giant has reportedly patented a new version of Alexa designed to analyze speech and identify signs of illness, according to the report. […]
FDA: TearLab’s Discovery MMP-9 test 510(k) fails to meet substantial equivalence
TearLab Corp. (OTC:TEAR) said this week that the FDA ruled that the company’s 510(k) submission for its TearLab Discovery MMP-9 test, designed to measure an inflammatory biomarker found in tears, did not meet criteria for substantial equivalence. The San Diego-based company’s TearLab Discovery lab-on-a-chip platform is intended to analyze multiple biomarkers in human tears with nanoliter […]
FDA releases BD lock flush syringe facility warning letter
The FDA this week released a warning letter it sent to Becton Dickinson (NYSE: BDX) last month over issues it found at the company’s Franklin, Wisc.-based facilities, which produces pre-filled Heparin and 0.9% sodium chloride lock flush syringes. The warning letter came from an inspection of the facilities which took place between May 16, 2018 and August […]
Concept Medical raises $60m for sirolimus-coated balloon IDE trial
Medtech developer Concept Medical said yesterday it received $60 million from cardiologist and serial entrepreneur Dr. Kiran Patel to support pursuit of an FDA investigational device exemption trial for its sirolimus-coated balloon device. The Florida-based company touted the device as the world’s first sirolimus-coated balloon, and said that funds will also be used to support […]
Report: Drug delivery investments down in Q3
Investment spending in the drug delivery sector has dropped significantly for the third quarter, but is staying ahead of last years numbers year-to-date, according to a new report. Venture capital investments fell a significant 61.8% to $29.6 million during the three months ended September 30, though deal volume stayed the same when compared to the […]
DelCath closes $8m rights offering
Delcath Systems (NSDQ:DCTH) said yesterday it closed a previously announced rights offering bringing in approximately $8.1 million. The New York-based company said that it received approximately 4.3 million basic subscriptions and 418,207 oversubscriptions for a total of approximately 4.7 million subscriptions. Each subscription equates to a single share of Delcath’s common stock, the company said, with […]
