A clinical trial of the Guardian implantable heart attack monitor made by Angel Medical Systems failed to meet its efficacy endpoint, but suggested that the device could be used to help detect “silent” heart attacks. Wilmington, Del.-based AngelMed won FDA clearance a year ago for the Guardian device for patients with prior acute coronary syndrome […]
Angel Medical Systems Inc.
Angel Medical Systems clears bankruptcy, raises $10m
Angel Medical Systems has raised $10 million in a new equity round of financing after clearing its Chapter 11 bankruptcy plans. The Eatontown, N.J.-based company developed the FDA-cleared AngelMed implantable cardiac monitor system intended for patients who had prior acute coronary syndrome events, including myocardial infarctions or unstable angina, and who remained at high risk for recurrent […]
Angel Medical Systems wins approval for Chapter 11 bankruptcy plan
Angel Medical Systems has won approval for its planned Chapter 11 bankruptcy, according to recently released Delaware bankruptcy court documents. The Eatontown, N.J.-based company developed the FDA-cleared AngelMed implantable cardiac monitor system intended for patients who had prior acute coronary syndrome events, including myocardial infarctions or unstable angina, and who remained at high risk for […]
Angel Medical Systems files for Chapter 11 bankruptcy
Cardiac monitor developer Angel Medical Systems has filed for Chapter 11 bankruptcy, according to recently posted court documents. In its petition forms, the Eatontown, N.J.-based company lists the BioInfo Accelerator Fund as its largest creditor, owing it approximately $43 million. The owed amounts are for a combination of $20.6 million in 2012 notes, $20.4 million […]
FDA approves Angel Medical System’s AngelMed Guardian cardiac monitor
The FDA this week approved Angel Medical Systems AngelMed Guardian implantable cardiac monitor system after the device had previously been rejected unanimously by an FDA advisory panel in 2016. The initial rejection came after the Tinton Falls, N.J.-based company presented partial data from its pivotal trial of the device in after having pulled the plug […]
Cartiva, Angel Medical win FDA PMA review dates
The FDA set dates with Cartiva and Angel Medical to review premarket approval applications for Cartiva’s Synthetic Cartilage Implant and Angel Medical’s Guardian cardiac monitor system, the companies said today. Alpharetta, Ga.-based Cartiva is slated to meet with the federal watchdog on April 20, to review the application for its SCI, which is designed to treat osteoarthritis […]
FDA sets panel date for Angel Medical’s implantable cardiac monitor
The FDA is slated to convene an advisory panel meeting to discuss Angel Medical Systems’s pre-market approval application for the AngelMed Guardian implantable heart monitor, the agency said today. The FDA’s Circulatory System Devices Panel is due to meet March 16 to discuss the PMA for the AngelMed Guardian, which is designed to detect the early heart problems […]
BiO2 Medical wins FDA nod for pivotal trial of Angel IVC catheter
BiO2 said it won an FDA nod for a pivotal trial of its Angel catheter and vena cava filter in the prevention of pulmonary embolism.
The 182-patient trial is a single-arm safety & efficacy study of the Angel device in patients at high risk for developing pulmonary embolism who can’t take standard drug therapies, according to a press release.
CardioKinetix signs option-to-buy agreement with Edwards Lifesciences; raises $50M | Medtech funding for the week of December 8, 2014
CardioKinetix raises $50m, inks buyout deal with Edwards Lifesciences
December 8, 2014 by Val Kennedy
Angel Medical raises $28M for pre-heart attack monitor | Wall Street Beat
Angel Medical Systems said it’s closed a funding round worth $28 million for its AngelMed Guardian implant, designed to detect the early heart problems that can lead to heart attacks and alert patients to seek medical care.
The round included existing backers and a new contribution from SOAM Angel Partners, which added principal Dr. Victor Whitman to Angel Medical’s board, according to a press release.
Teleflex affirms 2012 guidance | Wall Street Beat
Teleflex (NYSE:TFX) said yesterday that it expects its 2012 earnings to meet Wall Street’s expectations, but forecast softer profits for the coming year.
The Limerick, Pa.-based medical device company said its "preliminary financial goals" for 2013 are for sales growth of 11%-13% and adjusted EPS of $4.70-$4.90.
