SweynTooth Cybersecurity Vulnerabilities Put Dozens of Medical Devices at Risk
A family of 12 cybersecurity bugs associated with Bluetooth Low Energy (BLE) may introduce risks for some medical devices, FDA said Tuesday in a safety notice to patients, providers, and manufacturers.
The vulnerabilities, dubbed SweynTooth, don't exist in BLE itself but in development kits that come with certain system-on-a-chip (SoC) products. FDA said it is aware of several SoC manufacturers that are affected by these vulnerabilities:
Texas Instruments
NXP
Cypress
Dialog Semiconductors
Microchip
STMicroelectronics
Telink Semiconductor
Medical device manufacturers are already assessing...
Source: MDDI - March 4, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Source Type: news
Thermo Fisher Scientific Set to Acquire Qiagen for $11.5B
After months of rumors, Thermo Fisher Scientific is finally acquiring Qiagen for $11.5 billion. The deal calls for Waltham, MA-based Thermo Fisher Scientific to spend about $43.6 per share for Qiagen. The move also comes after Qiagen terminated talks for a merger on Christmas Eve.
The offer price represents a premium of about 23% to the closing price of Venlo, Netherlands-based Qiagen’s common stock on Monday. The proposed acquisition is set to close in the first half of 2021.
Thermo Fisher said the transaction is expected to be immediately accretive to its adjusted earnings per share after the close. It ...
Source: MDDI - March 3, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Business Source Type: news
Can AI Really Distinguish Between Back Pain?
This study is important because artificial intelligence can potentially more accurately distinguish whether the pain is acute or chronic, which would determine whether a patient should return to normal activities quickly or rest and schedule follow-up visits with a physician. This study also has implications for diagnosis, treatment, and billing purposes in other musculoskeletal conditions, such as the knee, elbow, and shoulder pain, where the medical codes also do not differentiate by pain level and acuity."
 (Source: MDDI)
Source: MDDI - March 3, 2020 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Source Type: news
Amcor Joins Healthcare Plastics Recycling Council
Amcor has joined the Healthcare Plastics Recycling Council (HPRC), a consortium of companies seeking to improve the recyclability of healthcare plastic products and packaging. Amcor will support HPRC with expertise in packaging design for medical devices and applications in hospitals and other treatment settings, it reported in a news release.
Amcor sees an opportunity for collaboration within the healthcare industry. “Patient safety and product protection will always come first in any medical packaging innovation, whilst at the same time Amcor strives to also protect our planet through the development of...
Source: MDDI - March 3, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Packaging Source Type: news
Most Provocative Statements Heard at MD & amp;M West 2020
Join us next year at MD&M West, Feb. 9-11, 2021. (Source: MDDI)
Source: MDDI - March 2, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Source Type: news
Why NuVasive & #039;s Pulse Delay Is Actually a Good Thing
Spine surgeons will have to wait a little longer than previously expected to get their hands on NuVasive's Pulse surgical automation platform, which FDA cleared last July. The San Diego, CA-based company has decided to spend most of 2020 further refining the platform based on beta testing insights. Commercial launch is now expected in 2021.
Pulse is single platform designed to combine neuromonitoring, surgical planning, rod bending, radiation reduction, imaging, and navigation in order to address many of the challenges spine surgeons face. The company is also developing a robotics application for Pulse in parallel.
A 6% st...
Source: MDDI - March 2, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Researchers Discover Interesting Imaging Features for Coronavirus
There could be some significant overlap with the imaging similarities with the novel coronavirus disease 2019 (COVID-19), the secure acute respiratory syndrome (SARS) and the Middle East respiratory syndrome (MERS). The findings will be presented in the American Journal of Roentgenology (AJR).
Chest imaging plays a vital role in both assessments of disease extent and follow-up.
As per her review of the present clinical literature concerning COVID-19, Melina Hosseiny of the University of California at Los Angeles said in a release: "Early evidence suggests that initial chest imaging will show abnormality in at least 85% of ...
Source: MDDI - March 2, 2020 Category: Medical Devices Authors: MDDI Staff Tags: Imaging Source Type: news
FDA Strikes Hard at Coronavirus Outbreak with New Policy
FDA is upping its response to address the novel coronavirus outbreak. The policy is aimed at laboratories seeking to develop diagnostic tests for the coronavirus.
The policy allows laboratories to develop and begin to use the diagnostics before FDA has completed a review of their Emergency Use Authorization (EUA) requests.
"We believe this policy strikes the right balance during this public health emergency," said FDA Commissioner Stephen M. Hahn, M.D. "We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from FDA, while quickly expanding testing capa...
Source: MDDI - March 2, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Regulatory and Compliance Source Type: news
Medtech in a Minute: Feeling the Coronavirus Pinch, J & amp;J & #039;s Apple Study, and More
Coronavirus Hurts Big Medtech's Bottom LineÂ
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. Boston Scientific, for example, expects the virus to lower first-quarter revenue by $10 million to $40 million.
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J&J and Apple Have Big Hopes for Heartline Study
Johnson & Johnson’s Janssen Pharmaceutical unit and Apple opened enrollment for the Heartline Study, which aims to ...
Source: MDDI - March 2, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Verily Partnership Could Play a Big Role in iRhythm ’s Future
iRhythm Technology’s work with Verily could play an important role for the company this year. The San Francisco, CA-based firm discussed its work with Verily during its 4Q19 earnings call late last week.
The two companies first announced the collaboration in September of 2019. Under the agreement, iRhythm will develop offerings that could work with Verily’s Study Watch, which recently received FDA clearance.
According to a transcript of iRhythm’s 4Q19 earnings call from Seeking Alpha, the firm’s CEO Kevin King said, “Through our partn...
Source: MDDI - February 28, 2020 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Source Type: news
Medtronic Rumored to Be Looking at a Deal with LivaNova
Reorg Research reported that Medtronic is in early-stage acquisition talks with LivaNova, news that has been well received by LivaNova shareholders. The firm said Medtronic would subsequently break up LivaNova, keeping its neuromodulation business and selling its cardiovascular business. The article does note, however, that Boston Scientific, Edwards Life Sciences, and Johnson & Johnson may also be interested in the London-based company.
Mike Matson, an analyst at Needham & Co., performed a sum-of-parts analysis that values LivaNova's cardiovascular and neuromodulation businesses separately. His analysi...
Source: MDDI - February 28, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Cardiovascular Source Type: news
The Anatomy of a Medical Device Startup
The singular purpose and focus on results with relentless execution is critical to the success of any startup, according to Siddharth Desai, technical leader and president at Health Care Evolution Inc. During a session at MD&M West 2020, Desai talked about how a startup's approach to product development compares to the approach typically seen at larger, more conventional organizations. (Source: MDDI)
Source: MDDI - February 28, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Business Source Type: news
Supplier Stories for the Week of February 23
(Source: MDDI)
Source: MDDI - February 27, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Molding Source Type: news
Aria CV Wants to Offer a Device Option for Pulmonary Arterial Hypertension
Aria CV is venturing into a space that few medtech companies have gone before. The St. Paul MN-based company is developing an implantable device to tackle Pulmonary Arterial Hypertension (PAH), a disease that is mostly treated with pharmaceuticals.
Earlier this week, the company raised $31 million in a series B round to help fund an early feasibility study in the U.S. for the Aria CV Pulmonary Hypertension System (Aria CV PH System).
The series B round was led by Xeraya Capital. Also participating in the financing were Longview Ventures, Catalyst Health Ventures, BioStar Ventures, Cedar Point Capital, Frontcourt Group, and...
Source: MDDI - February 27, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news
LivaNova and Verily in Research Agreement to Treat Depression
LivaNova has entered into a research partnership with Verily Life Sciences, an Alphabet company, to evaluate the effectiveness of Vagus Nerve Stimulation (VNS) therapy for Difficult to Treat Depression (DTD). The collaboration comes a few short months after London-based LivaNova ended its transcatheter mitral valve replacement (TMVR) program because of continued declines in revenue from its valve business.
In the RECOVER clinical study, LivaNova and Verily aim to gather quantitative data on patient behavior using technology and analytics developed by Verily to further understand depressive episodes and a patientâ...
Source: MDDI - February 27, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news
