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Featured

Bigfoot Biomedical inks insulin deal with Eli Lilly

January 7, 2019 By Sarah Faulkner

Bigfoot Biomedical said today that it inked a non-exclusive deal with Eli Lilly (NYSE:LLY) to integrate Eli Lilly’s insulin products into Bigfoot’s investigational insulin delivery devices. The California-based company expects to launch its first two insulin delivery systems – Bigfoot Inject and Bigfoot Loop – in 2020, contingent upon finishing a pivotal trial and landing regulatory approvals. Get […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Pharmaceutical, Wall Street Beat Tagged With: Abbott, Bigfoot Biomedical, Eli Lilly & Co.

Dexcom Q4 prelims top consensus | Wall Street Beat

January 7, 2019 By Sarah Faulkner

Dexcom (NSDQ:DXCM)  topped estimates on Wall Street today with preliminary results for its fourth-quarter financial results. The San Diego, Calif.-based company said it expects to report $331 million in sales for the quarter ended Dec. 31 – up at least 50% from the same period last year. Get the full story at our sister site, Drug […]

Filed Under: Business/Financial News, Featured, Funding Roundup, Wall Street Beat Tagged With: apyxmedical, Bovie Medical Corp., Dexcom, intersectent, TransEnterix

Abiomed jumps on fiscal Q3 prelims, raised outlook | Wall Street Beat

January 7, 2019 By Brad Perriello

Abiomed (NSDQ:ABMD) shares got a jump today from its preliminary fiscal third-quarter numbers and an improved outlook for the rest of its fiscal year. The Danvers, Mass.-based heart pump maker said it expects to post fiscal Q3 sales of roughly $200.6 million, representing a 30.3% increase over its fiscal Q3 top line. Abiomed also raised […]

Filed Under: Featured, MassDevice Earnings Roundup, Wall Street Beat Tagged With: Abiomed, Cardiovascular Systems Inc., CAS Medical Systems Inc., Nuvasive, wrightmedical

JC Medical touts first U.S. treatment with transfemoral TAVR system

January 7, 2019 By Sarah Faulkner

JC Medical said today that the company’s first U.S.-based patient was treated with its transfemoral transcatheter aortic valve implant system, J-Valve TF. The FDA approved the use of J-Valve for people with aortic regurgitation through its “compassionate use” pathway. JC Medical also noted that it’s gearing up for a clinical trial of the investigational device in […]

Filed Under: Cardiovascular, Featured, Replacement Heart Valves, Vascular Tagged With: JC Medical

Monteris Medical had a serious recall: Here’s what their CEO did

January 4, 2019 By Chris Newmarker

Soon after Marty Emerson took over as CEO of Monteris Medical, he and other company officials realized that the company’s robot-assisted brain surgery device had a serious overheating problem. Here’s how he led the company through the crisis. Marty Emerson became CEO of Monteris Medical (Plymouth, Minn.) in July 2016. Within a month, the first […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Neurological, News Well, Recalls, Regulatory/Compliance, Robotics, Surgical Tagged With: Monteris Medical

Obalon plunges on trimmed 2018 sales guidance

January 4, 2019 By Brad Perriello

Obalon Therapeutics (NSDQ:OBLN) shares took a big hit yesterday and continued their slide today after the weight loss balloon maker said it expected to hit the low end of its 2018 sales guidance. Carlsbad, Calif.-based Obalon said last year’s revenues are headed toward the low end of its prior outlook for $9.0 million to $9.9 […]

Filed Under: Featured, Wall Street Beat, Weight loss

Minerva Surgical raises $9m for endometrial ablation tech

January 4, 2019 By Sarah Faulkner

Minerva Surgical has raised $9.2 million from 17 investors as part of a $10 million offering, according to a document filed with the SEC this week. The Redwood City, CA.-based company makes the Minerva endometrial ablation system – a treatment designed to help women manage heavy menstrual bleeding. Heaving bleeding, which occurs in women between […]

Filed Under: Featured, Funding Roundup, Women's Health Tagged With: Minerva Surgical Inc.

Endologix recalls Nellix stent graft, bans off-label use

January 4, 2019 By Brad Perriello

Endologix (NSDQ:ELGX) said today that it’s halting the unrestricted sale of its Nellix stent graft for treating abdominal aortic aneurysms and limiting its use to pre-screened patients under a clinical protocol. “We monitor the performance of the Nellix system through clinical trials, our complaint monitoring system, physician interaction and available publications,” CMO Dr. Matt Thompson said […]

Filed Under: Featured, Recalls, Regulatory/Compliance, Stent Grafts Tagged With: Endologix

AngioDynamics beats The Street with Q2 results

January 4, 2019 By Sarah Faulkner

Shares in AngioDynamics (NSDQ:ANGO) rose today after the medical device maker topped expectations on Wall Street with its second quarter financial results. The Latham, N.Y.-based company posted profits of $2.1 million, or 6¢ per share, on sales of $91.5 million for the 3 months ended Nov. 30, for sales growth of 5.5% compared with the same […]

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, Oncology, Vascular, Wall Street Beat Tagged With: AngioDynamics

Senseonics touts first U.S. trial implant of 180-day CGM

January 4, 2019 By Sarah Faulkner

Senseonics (NYSE:SENS) said yesterday that its Eversense XL 180-day continuous glucose sensor was implanted into the first participant of a trial designed to support a pre-market application to the FDA. The company’s 180-patient Promise trial is slated to study the safety and efficacy of the Eversense device in people with diabetes over 180 days. Get the […]

Filed Under: Clinical Trials, Diabetes, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Wall Street Beat Tagged With: Senseonics

Verily eyes new deals with $1B to back them

January 4, 2019 By Sarah Faulkner

Alphabet‘s (NSDQ:GOOGL) life sciences group, Verily, said yesterday that it raised $1 billion from a group of investors, including private equity firm Silver Lake and the Ontario Teachers’ Pension Plan. The company plans to use its newly-raised funds to support strategic partnerships and potential acquisitions. In a statement, Verily announced that Alphabet’s chief financial officer, […]

Filed Under: Business/Financial News, Featured, Funding Roundup, Wall Street Beat Tagged With: Alphabet (Google), Verily

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