Boston Scientific (NYSE:BSX) said today that it acquired Iris transcatheter annuloplasty ring developer Millipede in a deal worth approximately $325 million with the opportunity for an additional $125 million based on a commercial milestone. Santa Rosa, Calif.-based Millipede makes the Iris transcatheter annuloplasty ring for treating mitral valve regurgitation. Marlborough, Mass.-based Boston Scientific initially invested $90 million […]
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Cardiovascular Systems touts first patients treated with Teleport microcatheter
Cardiovascular Systems (NSDQ:CSII) touted today that the first patients in the U.S. were treated with the OrbusNeich Teleport microcatheter. The device, which recently won 510(k) clearance with the FDA, enables safe guidewire exchange during cardiovascular procedures. The Teleport product features a robust tip to provide access to challenging lesions, according to Cardiovascular Systems. Dr. Annapoorna Kini, […]
Venus Medtech completes Keystone Heart merger
Chinese transcatheter heart valve maker Venus Medtech said today that it closed its merger with Keystone Heart. Privately-held Keystone Heart sells TriGuard embolic protection devices that are designed to protect the brain during transcatheter aortic valve replacement and other cardiac procedures. Hoping for FDA approval in the third quarter of 2019, Keystone Heart is enrolling patients […]
DermaSensor raises $5.8m for handheld cancer detection device
DermaSensor has raised $5.8 million from 23 investors in an offering that began in November, according to a report filed with the SEC this month. The Florida-based company’s handheld device uses a light-emitting tip to evaluate potentially cancerous lesions on the surface of a patient’s skin. Using precision optics, the device can detect cellular pathological […]
Acorda wins FDA nod for inhaled Parkinson’s therapy
Acorda Therapeutics (NSDQ:ACOR) said this week that the FDA approved its Inbrija device for the intermittent treatment of “off” episodes in people with Parkinson’s disease. The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes are caused by low levels of dopamine between doses of the standard oral Parkinson’s […]
Delcath inks European licensing deal for Chemosat
Delcath Systems (OTC:DCTH) said this week that it inked a licensing deal with Germany-based medac for the commercialization of Chemosat in Europe. According to the terms of the seven-year agreement, Delcath’s European subsidiary will exclusively license its Chemosat system to Medac for sale in the EU, Norway, Liechtenstein, Switzerland and the UK. Medac is slated to […]
FDA approves Teva’s digital COPD, asthma inhaler
Teva (NYSE:TEVA) said this week that the FDA approved its ProAir Digihaler device – a digital inhaler that uses sensors to connect to a companion mobile app for people with asthma and chronic obstructive pulmonary disease. The company’s device features built-in sensors that can measure inspiratory flow and detect when the inhaler is used. After the […]
Varian wins US tariff exclusion for Chinese-produced Halcyon systems
Varian Medical (NYSE:VAR) said today that the U.S. Trade Representative granted it a tariff exemption for its Halcyon radiotherapy system, which would normally be subject to Section 301 tariffs due to it being manufactured in China. The Palo Alto, Calif.-based company said that the exception will have a less than $1 million impact on its financial results […]
Boston Scientific inks financing deal to fund $4B BTG acquisition
Boston Scientific (NYSE:BSX) has inked a number of new lending agreements, including a large credit facility it could use to finance its approximately $4 billion acquisition offer for British medical device maker BTG (LON:BTG), according to recently posted SEC filings. The Marlborough, Mass.-based company said that it entered into a term loan credit agreement with Barclays Bank […]
FDA braces for partial government shutdown
The FDA is preparing for a possible government shutdown after President Donald Trump said he will not sign a continuing resolution to keep the government open through February unless it includes funding for a border wall, which his opposition has stated they will not approve. Even in a shutdown, essential public-health related employees at the […]
UPDATE: FDA updates on post-market study revisions, oversight for Bayer’s Essure
Updated to include response from Bayer. The FDA today released steps it is taking to maintain its oversight of Bayer‘s (ETR:BAYN) Essure permanent birth control device following its removal from the U.S. market this summer, including extensions and revisions to a required post-market study of the device. In an official posting, FDA Commissioner Dr. Scott […]
