Will the Clouds Clear for Inogen This Year?
After years of flying through clear skies, Inogen encountered significant turbulance in 2019 that hurt the company's revenue growth and profitability. The company's troubles are not quite in the rearview mirror yet, but there are signs that the clouds are beginning to clear.
"While we have our challenges, we believe we can create long-term shareholder value by focusing on increasing patient and physician awareness of our products," said Scott Wilkinson, president and CEO of Goleta, CA-based Inogen.
The company, which makes portable oxygen concentrators and related accessories, had to navigate through volatility...
Source: MDDI - February 27, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Coronavirus Hits Big Medtech Where It Hurts Most – Revenue
As the Chinese healthcare system focuses on containing the spread of the coronavirus, medical device companies doing business in China are seeing lower procedure volumes, which means lower-than-expected revenue in the first quarter. Potential supply chain disruptions could further impact top-line growth for some medical device companies.
Boston Scientific expects the virus to lower first-quarter revenue by $10 million to $40 million, according to an earnings call earlier this month transcribed by SeekingAlpha.
"While we're still in the very early stages of assessing the impact and highly focused on supporting o...
Source: MDDI - February 27, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Senseonics Eyes Longer-Term CGM Sensor
Senseonics had all the right ingredients to pull in strong earnings in 2019. The continuous glucose monitoring (CGM) specialist had a strong product on the market and significant reimbursements – yet the company fell short of expectations.
Now Senseonics is coming into 2020 with all guns firing. The Germantown, MD-based company is making headway in developing a longer-term CGM sensor. FDA gave Senseonics the greenlight to have a subgroup of the PROMISE study participants to continue for a total of one year to gather feasibility data on the safety and accuracy of the 365-day Eversense sensor.
In a release,...
Source: MDDI - February 26, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Wearable to Power Remote Care and Clinical Trials
Within a few weeks of announcing FDA clearance and the launch of BioSticker, a single-use wearable for monitoring patient health, BioIntelliSense Inc. reports the sensor will be employed in two different remote patient monitoring programs.
The FDA-cleared BioSticker medical device is designed to be worn comfortably on the upper left chest for effortless continuous vital sign monitoring for up to 30 days on a single use device, Jim Mault, CEO of BioIntelliSense, told MD+DI. “BioSticker device allows for the continuous remote monitoring of a patient’s vital signs—respirat...
Source: MDDI - February 26, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Digital Health Source Type: news
J & amp;J and Apple Begin Enrollment for Heartline Study
In the past few years, Apple has greatly increased its presence in healthcare. The Cupertino, CA-based company has received FDA nods for apps associated with its technology and has found itself in several clinical trials.
Most recently, the tech giant is seeing some movement in its partnership with Johnson & Johnson’s Janssen Pharmaceutical unit.
The companies just opened enrollment for the Heartline Study, which is designed to explore if the Heartline Study app on iPhone and heart health features on Apple Watch can improve health outcomes, including reducing the risk of stroke, with earlier detection...
Source: MDDI - February 26, 2020 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Cardiovascular Source Type: news
Robotics Could Assist Surgeons with One More Thing: Real-Time Training
Teaching surgical residents has been a practice that is relatively unchanged over the course of decades and even, perhaps, centuries. Instruction by observation and eventual supervised hands-on practice forms the basis of the transfer of knowledge and skill between an experienced surgeon and a beginner. These practices have produced competent surgeons who, ideally, perfect their techniques and approaches over the years.
Training is ultimately limited by the perceptual limits of what a resident can observe and how a surgeon can critique the hands-on efforts of residents. The operating room setting also places some limits on...
Source: MDDI - February 25, 2020 Category: Medical Devices Authors: Bruce Lichorowic Tags: Assembly and Automation Source Type: news
Co-Diagnostics Grabs CE Mark for Coronavirus IVD
Co-Diagnostics has been part of the coronavirus conversation for the past two months. Whether it’s been educating the public about the disease or developing diagnostics for the virus, the company has been at the forefront.
Now the Salt Lake City, UT-based company has received CE mark for the Logix Smart Coronavirus COVID-19 Test, an in vitro diagnostic (IVD).
Co-Diagnostics said it shipped samples of the Research Use Only version of its test to distributors in Italy and Germany last week, which allowed future customers to confirm the quality and sensitivity of the product prior to the IVD being available,...
Source: MDDI - February 25, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Regulatory and Compliance Source Type: news
SABIC Introduced New Polycarbonate Copolymers
At MD&M West 2020 SABIC debuted its new family of LNP ELCRES CRX polycarbonate (PC) copolymers to offer medical device manufacturers a new approach to chemical resistance. Using the new materials could allow medical device manufacturers to lengthen product lifecycles to meet warranty expectations and could reduce replacement claims, Darpan Parikh, global product management leader, LNP Specialty Compounds at SABIC, told MD+DI.
“Aggressive cleaners are being used in hospitals to prevent healthcare-associated infections,†Parikh explained. The risks for medical devices, however, are mat...
Source: MDDI - February 25, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Materials Source Type: news
Let ’s Face It, the Robots Aren’t Coming, They’re Already Here!
The robots are here. For years Intuitive Surgical has remained relatively unchallenged in the surgical robotics market. The Sunnyvale, CA-based company has had the da Vinci robot on the market since 2,000, and no other firm has come close to matching its impact in the industry.
But Medtronic and Johnson & Johnson are hard-pressed on giving it a try. Separately, the two companies have been building robotics solutions that will undoubtedly be competitors to Intuitive’s da Vinci.
New Brunswick, NJ-based Johnson & Johnson found a nice entry point to compete through the Verb joint venture with Verily L...
Source: MDDI - February 24, 2020 Category: Medical Devices Authors: Omar Ford Tags: Assembly and Automation Source Type: news
Medical Devices and the Ransomware Menace
The first ransomware attack on a medical device was reported on a precision appliance during the 2017 WannaCry attacks. Since then, cybercriminals haven’t slowed down. Over the past 12 months, ransomware perpetuators have been relentless in their efforts to solicit payments from unsuspecting victims, even going as far as threatening to publish data if the ransom is not paid.
This new tactic, in addition to the emergence of newer and prolific ransomware variants like Ryuk and Sodinokibi, has proven to be successful, too. In Q4 2019, the average ransomware payment increased by 104 percent from the previous ...
Source: MDDI - February 24, 2020 Category: Medical Devices Authors: Sam Roguine Tags: Software Source Type: news
Onduo ’s Survey Finds the Use of CGMs to Be Highly Effective for Patients
Participants involved in a survey conducted by Onduo found continuous glucose monitors (CGM) to be highly effective. The results were presented at the 13th International Conference on Advanced Technologies & Treatments for Diabetes held in Madrid, Spain last week.
The satisfaction survey was completed by 594 members who wore a CGM from March 2018 through July 2019.An overwhelming majority of survey participants (95% or greater) reported that the use of CGM helped increase their diabetes knowledge, including the impact of eating and taking medications.
Survey respondents also reported being highly satisfied with the eas...
Source: MDDI - February 24, 2020 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Source Type: news
Medtech in a Minute: Recalls, Insulet CGM Partnerships, and More
Class I Recalls for Abbott and Medtronic
Both Abbott Laboratories and Medtronic faced Class I Recalls last week. Abbott faced a recall of specific lots of its NC Trek RX Coronary Dilatation Catheter. Medtronic’s MiniMed Insulin Pump was the subject of a recall.
Insulet Corners CGM Market with Two High Profile Collaborations
Last week, Insulet revealed it had snared two partnerships that will help it continue its strong momentum in the continuous glucose monitoring (CGM) market. The Billerica, MA-based company signed agreements with both Abbott Laboratories and DexCom.
Grail Keeps Cranking Out Milestones
T...
Source: MDDI - February 22, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
What ’s New in Medtech Materials
(Source: MDDI)
Source: MDDI - February 21, 2020 Category: Medical Devices Authors: MD+DI Staff Tags: Materials Source Type: news
Philips Seeks Better Understanding of PCI Outcomes Through New Trial
Philips is continuing its investment into percutaneous coronary intervention (PCI) procedures through a new study. The company announced the (Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect: Guided Physiologic Stenting) (DEFINE GPS) global multicenter study, which has a goal to assess outcomes of PCI procedures guided by integrated iFR and interventional X-ray images. The announcement of the study comes on the heels of Philips making a bid to shed its appliances unit so it can focus on healthcare.Â
The primary endpoint is target vessel failure (a composite o...
Source: MDDI - February 21, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Imaging Source Type: news
Cardiovalve Reaches 2 Milestones for its Tricuspid Valve Replacement System
Cardiovalve has a pair of milestones that could help catapult the company into the forefront of the tricuspid valve market. The Or Yehuda, Israel-based company received FDA approval for an early feasibility study of the transcatheter tricuspid valve replacement system and Breakthrough Device Designation for the technology.
The study’s primary endpoint is the safety and feasibility of the Cardiovalve technology and procedure in reducing tricuspid regurgitation, with evaluations at 30 days and periodically up to five years. The study will be conducted in collaboration with five leading US hospitals.
In a re...
Source: MDDI - February 21, 2020 Category: Medical Devices Authors: Omar Ford Tags: Regulatory and Compliance Cardiovascular Source Type: news
